New Antibody-Drug combo targets Hard-to-Treat cancers

NCT ID NCT05797168

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests a new drug called AZD5335, alone or with other cancer medicines, in people with advanced solid tumors like ovarian, lung, and endometrial cancers. The goal is to see if the drug is safe, tolerable, and shows signs of shrinking tumors. About 506 participants will take part in this early-phase trial.

What this could mean

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

Active substance: Torvutatug samrotecan (AZD5335), an antibody-drug conjugate
What this could lead to: If successful, this could lead to a new treatment option for advanced ovarian, lung, and endometrial cancers.
What could go wrong: This is an early-phase trial (Phase 1/2a) focused on safety and dosing, so it is uncertain if the drug will be effective. Side effects may occur, and the trial is small.

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

About 602 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Aug 2028

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 to 130 years

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.

Core Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study. * Participant must be ≥ 18 years at the time of signing the informed consent. * Willing to provide adequate archival and/or baseline tumor sample as applicable per module-specific criteria. * For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required unless the most recent archival tissue sample was collected after receipt of such treatment. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he/she was informed about all therapeutic options. * Participants must have measurable disease per RECIST v1.1, 1. A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined. 2. For participants who undergo biopsies at screening and/or on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation. * Life expectancy ≥ 12 weeks. * Adequate organ and marrow function. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. (a) Male participants: (i) Male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus an additional contraceptive method) post-screening for at least 8 months following the last dose of study intervention. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period. In addition, male participants must refrain from freezing or donating sperm while on study and for 8 months following the last dose of study intervention. (b) Female participants : (i) Females of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to receiving the first dose of study intervention and a negative urine or serum pregnancy test prior to starting their next cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. (ii) (ii) Sex and Contraceptive/Barrier Requirements: Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \[(periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\], a vasectomized partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo Provera™ injections, oral contraceptive associated with inhibition of ovulation, and Evra Patch™, Xulane™, or NuvaRing®. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly), from enrolment throughout the study and for 8 months following the last dose of study intervention. The male partner of a female participant of childbearing potential must also use a male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. In addition, female participants must not donate or retrieve for their own use, ova while on study and for 8 months following the last dose of study intervention. Core Exclusion Criteria: * Patients with spinal cord compression or a history of leptomeningeal carcinomatosis. * Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to first dose of study intervention. * Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention. * Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \[NCI\] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible. * Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen \[HBsAg\] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350/mm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). Patients with a past or resolved HBV/HCV infection are eligible if: 1. Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or 2. Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below: (i) HBV DNA viral load \<100 IU/mL. (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<3 x upper limit of normal (ULN), which are not attributable to HBV infection. (iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator or as per local guideline. Note for Japan: Japanese patients with positive anti-HBs/anti-HBc and negative HBsAg will be assessed following local guidelines. (c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA. * Patient has active ILD/pneumonitis or has a history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible. * History of another malignancy except for: * Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated carcinoma in situ without evidence of disease. * Localized non-invasive solid organ primary disease under surveillance. * Patients with any of the following cardiac criteria: * History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for: (i) Rate controlled asymptomatic atrial fibrillation. * NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention. * Uncontrolled hypertension. * Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening. * History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening. * Symptomatic heart failure (as defined by New York Heart Association class ≥ 2). * Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement. * Severe uncorrected valvular heart disease. * Mean resting QTcF \> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes. * Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or unexplained sudden cardiac death under 40 years of age. * Uncontrolled and/or unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including psychiatric illness) and/or social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent. * Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator. * Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 3 months after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit/risk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \> 72 hours prior to study intervention initiation or after completion of the DLT period. * For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period. * Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the Sponsor. * Patients with a known hypersensitivity to study intervention or any of the excipients of the product. * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). * Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. * Previous enrolment in the present study. \*\*Other module specific criteria may apply

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung endometrial cancer endometrium neoplasm lung adenocarcinoma neoplasm ovarian cancer squamous cell lung carcinoma

As listed by the trial registrant

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

Endometrial cancer Lung adenocarcinoma Lung squamous cell carcinoma Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

57 sites in 12 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site
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Duarte, California, 91010, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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Aurora, Colorado, 80045, United States
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Louisville, Kentucky, 40202, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48201, United States
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Columbus, Ohio, 43201, United States
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Portland, Oregon, 97239, United States
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Providence, Rhode Island, 02903, United States
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Providence, Rhode Island, 02905, United States
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Houston, Texas, 77030, United States
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Fairfax, Virginia, 22031, United States
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Liverpool, 2170, Australia
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Melbourne, 3000, Australia
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Edmonton, Alberta, T6G 1Z2, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Chengdu, 610041, China
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Chongqing, 400030, China
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Guangzhou, 510000, China
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Guangzhou, 510060, China
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Jinan, 250117, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Berlin, 13353, Germany
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Essen, 45136, Germany
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Freiburg im Breisgau, 79106, Germany
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Hanover, 30625, Germany
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Leipzig, 04103, Germany
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Mannheim, 68167, Germany
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Regensburg, 93053, Germany
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Haifa, 3109601, Israel
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Ramat Gan, 52621, Israel
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Hidaka-shi, 350-1298, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Sunto-gun, 411-8777, Japan
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Tokyo, 104-0045, Japan
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11259, Taiwan
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Ankara, 06050, Turkey (Türkiye)
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Ankara, 06200, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Istanbul, 34718, Turkey (Türkiye)
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Cambridge, CB2 0XY, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Sutton, SM2 5PT, United Kingdom

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