New Antibody-Drug conjugate shows promise for Hard-to-Treat cancers

NCT ID NCT04152499

Disease control Sponsor: Klus Pharma Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a new drug called SKB264 in people with advanced solid tumors that have not responded to standard therapies. The drug is an antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells. The trial includes over 1,400 participants with various cancers such as lung, breast, ovarian, and stomach cancer. The goal is to find the safest dose and see if the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SKB264 (also called Sacituzumab Tirumotecan), an antibody-drug conjugate that targets TROP2 on cancer cells
What this could lead to: If successful, this could provide a new treatment option for people with advanced cancers that have stopped responding to other therapies.
What could go wrong: This is an early-phase trial, so the drug may not shrink tumors or improve survival. Side effects could be serious, and results may not apply to all cancer types studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

1,410 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Diagnosis and Main Criteria for Inclusion: Inclusion Criteria: Patients must meet the following criteria for inclusion into the study: Phase I: 1. Patients must be able to provide documented voluntary informed consent. 2. Male or female patient aged 18-75 years. 3. Histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include but not limited to the following tumor types: Breast cancer Ovarian epithelial cancer Non-small cell lung cancer Gastric adenocarcinoma Small cell lung cancer Urothelial carcinoma Note: Confirmation of TROP2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from fresh or archived materials for determination of TROP2 expression. 4. Measurable disease by CT/MRI during dose escalation. 5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or standard treatment is not applicable at this stage. 6. Granulocyte count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. 7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN. 8. Serum bilirubin ≤ 1.5 mg/dL (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled)., aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN). 9. Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas. Note that 24 hour urine collection is not required but is allowed. 10. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 7 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence. * Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom. * Women are excluded from birth control if they had had tubal ligation or a hysterectomy. 12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. 13. Expected survival ≥ 3 months. Phase II: 1. Patients must be able to provide documented voluntary informed consent. 2. Male or female patient aged ≥ 18 years. 3. Histologically or cytologically documented, incurable, locally advanced, recurrent or metastatic cancer, including the following tumor types: * Cohort 1: triple negative breast cancer (\< 1% expression for estrogen receptor \[ER\] and progesterone receptor \[PR\] and HER2 negative) * Cohort 2: ovarian cancer, fallopian tube cancer, or primary peritoneal cancer * Cohort 3: non-small cell lung cancer * Cohort 4: gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (HER2 negative) * Cohort 6: HR+/ HER2- breast cancer (≥1% expression for ER and/or PR and HER2 negative) * Cohort 7: Head and neck squamous cell carcinoma (including primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Other primary tumor sites of HNSCC are not eligible) * Cohort 8: Endometrial carcinoma (including carcinosarcoma, but excluding sarcoma and neuroendocrine endometrial carcinoma) * Cohort 9: Urothelial carcinoma (including urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, patients with mixed histology are eligible provided urothelial component \> 50% and plasmacytoid component\<10%, patients whose tumors contain any neuroendocrine component are not eligible) * Cohort 10: Cervical cancer (including squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix) Note: Evaluation of TROP-2 expression is required. 4. Measurable disease by CT/MRI. 5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies. 6. Neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. 7. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN. 8. Serum bilirubin ≤ 1.5 ×ULN (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN). 9. Creatinine clearance ≥ 30 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 24 hour urine collection is not required but is allowed. 10. ECOG Performance Status 0 or 1. 11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 6 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence. * Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom. * Women are excluded from birth control if they had had tubal ligation or a hysterectomy. 12. Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. Note: Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. 13. Expected survival ≥ 3 months. Exclusion Criteria: Patients that meet the following criteria will be excluded from entry into the study: Phase I: 1. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia). 2. Symptomatic brain metastases or any radiation or surgery for brain metastases within 1 months of first infusion of study drug. 3. Subjects with second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years). 4. Require supplemental oxygen for daily activities. 5. Documented Grade ≥ 2 peripheral neuropathy. 6. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration. 7. Subjects previously treated with TROP 2 targeted therapies. 8. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug. 9. Any experimental therapy within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug. 10. Any major surgical procedure within 4 weeks of first infusion of study drug. 11. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis. 12. Have known prior positive test results or medical history for human immunodeficiency virus. 13. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%). 14. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III. 15. Pregnancy or lactation. 16. Left ventricular ejection fraction \< 45% determined by echocardiogram or multiple gated acquisition scan. 17. Resting QTc \> 480 msec at baseline. 18. Ascites requiring paracentesis ≥1 per week. 19. Symptomatic pleural effusion (\< 90% oxygen saturation). 20. Subjects with non-infectious interstitial lung diseases (ILD) or medical history of pneumonia requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases. 21. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed). 22. The investigator considers other situations that patients are not appropriate to participate in this trial. Phase II: 1. Any patient who was treated in the Phase I part of this study. 2. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia). 3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases. 4. Patients with active second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years, or other malignant cancers that have been cured and no evidence of recurrence). 5. Require supplemental oxygen for daily activities. 6. Documented Grade ≥ 2 peripheral neuropathy. 7. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration. 8. Patients previously treated with TROP 2 targeted therapies at any time for early stage or metastatic disease. 9. Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug. 10. Any experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug. 11. Any major surgical procedure within 4 weeks of first infusion of study drug. 12. Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis. 13. Have known prior positive test results or medical history for human immunodeficiency virus. 14. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%). 15. Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this Study. List of representative examples of strong inhibitors or inducers of CYP3A4 is provided in Appendix III. 16. Pregnancy or lactation. 17. Left ventricular ejection fraction \< 45% determined by echocardiogram or multiple gated acquisition scan. 18. Resting QTcF \> 480 msec at baseline. 19. Ascites requiring paracentesis \>1 per week. 20. Symptomatic pleural effusion (\< 90% oxygen saturation). 21. History of interstitial lung diseases (ILD) or non-infectious pneumonitis requiring steroid treatments; severe pulmonary dysfunction caused by lung diseases. 22. New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed). 23. Known allergic to any components of SKB264, including excipients (including polysorbate-20); or history of severe hypersensitivity to another biologic therapy. 24. The investigator considers other situations that patients are not appropriate to participate in this trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Carcinoma, Ovarian Epithelial cervical cancer endometrial carcinoma endometrium neoplasm gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma hormone receptor-positive breast cancer non-small cell lung carcinoma ovarian carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck transitional cell carcinoma triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Cervical cancer Endometrial carcinoma Epithelial ovarian cancer Gastric adenocarcinoma Gastroesophageal junction adenocarcinoma Head and neck squamous cell carcinoma Non-small cell lung cancer Small cell lung cancer Urothelial carcinoma

Contacts and locations

Locations

900TH Hospital of Joint Logistics Support Force

Fuzhou, Fujian, China
Affiliated Hospital of Binzhou Medical College

Binzhou, Shandong, China
Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China
Affiliated Hospital of Jining Medical College

Jining, Shandong, China
AnHui Provincial Cancer Hospital

Hefei, Anhui, China
Anhui Cancer Hospital

Hefei, Anhui, China
Anyang City Cancer Hospital

Anyang, Henan, China
Asan Medical Center

Seoul, South Korea
Beijing Cancer Hospital

Beijing, Beijing Municipality, China
Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China
CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea
Centro de Estudios Clínicos SAGA

Providencia, Chile
Centro de Investigacion Clinica Bradford Hill

Santiago, Chile
Chinese PLA General Hospital (301 Hospital)

Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China
Chongqing University Cancer Hosptital

Chongqing, Chongqing Municipality, China
First Hospital of Jilin University

Changchun, Jilin, China
Florida Cancer Specialists and Research Institute

Sarasota, Florida, 34232, United States
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China
Fujian Cancer Hospital

Fuzhou, Fujian, China
Fujian Medical University Uion Hospital

Fuzhou, Fujian, China
Gachon University Gil Medical Center

Incheon, South Korea
Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea
Gazi University Medical Faculty

Yenimahalle, Ankara, Turkey (Türkiye)
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China
Guangxi Medical University Cancer Center

Nanning, Guangxi, China
Hainan General Hospital

Haikou, Hainan, China
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Hubei Cancer Hospital

Wuhan, Hubei, China
Hunan Cancer Hospital

Changsha, Hunan, China
Inje University Haeundae Paik Hospital

Busan, South Korea
Jiangsu Province Hospital

Nanjing, Jiangsu, China
Jiangxi Cancer Hospital

Nanchang, Jiangxi, China
Jilin Cancer Hospital

Changchun, Jilin, China
Jinan Central Hospital

Jinan, Shandong, China
Kyungpook National University Chilgok Hospital

Daegu, South Korea
Liaoning Cancer Hospital

Shenyang, Liaoning, China
Los Angeles Hematology Oncology Medical Group

Glendale, California, 91204, United States
MD Anderson Cancer Center

Houston, Texas, 77030, United States
MUHC,Glen - Women's Health Research Unit

Montreal, Quebec, Canada
Mary Crowley Cancer Research

Dallas, Texas, 75230, United States
Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China
Nanyang Center Hospital

Nanyang, Henan, China
National Cancer Center

Goyang-si, South Korea
Neijiang Second People's Hospital

Neijiang, Sichuan, China
Obstetrics&Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China
Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States
Peking University Third Hospital

Beijing, Beijing Municipality, China
Pontificia Universidad Catolica de Chile - CICUC

Santiago, Chile
Princess Margaret Cancer Centre

Toronto, Ontario, Canada
Providence Cancer Institute, Franz Clinic

Portland, Oregon, 97213, United States
START MidWest

Grand Rapids, Michigan, 49546, United States
Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital

Seoul, South Korea
Severance Hospital, Yonsei University Health System

Seoul, South Korea
Shandong Cancer Hospital

Jinan, Shandong, China
Shanghai East Hospital

Shanghai, Shanghai Municipality, China
Shanghai General Hospital

Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital

Taiyuan, Shanxi, China
Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Sichuan Cancer Hospital

Chengdu, Sichuan, China
Sun Yat-Sen Memorial Hospital , Sun Yat-sen University

Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China
Sun Yat-sen University Cancer prevention Center

Guangzhou, Guangdong, China
Sunnybrook Research Institute

Toronto, Ontario, Canada
Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China
The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China
The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China
The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The First Hospital of Lanzhou University

Lanzhou, Gansu, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China
The Second Hospital of Anhui Medical University

Hefei, Anhui, China
The Second Hospital of Dalian Medical University

Dalian, Liaoning, China
The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
The first people's hospital of Lianyungang

Lianyungang, Jiangsu, China
Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China
Tongji Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China
University of California Los Angeles

Los Angeles, California, 90404, United States
Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States
Weifang People's Hospital

Weifang, Shandong, China
West China Hospital of Sichuan University

Chengdu, Sichuan, China
Wuhan Union Hospital of China

Wuhan, Hubei, China
Xiangya Hospital Central South University

Changsha, Hunan, China
Xiangya Hospital of Central South University

Changsha, Hunan, China
Xiangyang Central Hospital

Xiangyang, Hubei, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, China
Yibin Second People's Hospital

Yibin, Sichuan, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China
Zhejiang University School of Medical Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China
Zhengzhou Central Hospital

Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China
Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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