New cancer drug candidate BG-68501 enters first human trials
NCT ID NCT06257264
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a new drug called BG-68501 in people with advanced solid tumors that have not responded to standard treatments. The drug targets a protein (CDK2) that helps cancer cells grow. The trial will check safety, find the right dose, and see if the drug shrinks tumors, alone or with other drugs. About 103 adults with cancers like breast, ovarian, or lung cancer will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BG-68501 (a CDK2 inhibitor drug)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced solid tumors like breast, ovarian, and lung cancers.
- What could go wrong
- This is a very early Phase 1 trial with only 103 participants, so safety and effectiveness are not yet proven. Many early-stage drugs fail to show benefit.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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103 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Part 1 (Dose Escalation) Inclusion Criteria: * Monotherapy Cohorts: Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CDK2 dependency including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian cancer (PROC), endometrial cancer, and others. Prior available standard-of-care systemic therapies for advanced or metastatic disease are required. The requirements for enrollment into a food effect evaluation cohort are the same as the monotherapy cohorts with the exception that participants with gastric cancer and gastroesophageal adenocarcinoma are excluded. * Combination Cohorts (BG-68501 with fulvestrant with or without BGB-43395): Enrollment is restricted to only participants with HR+/HER2- BC. In regions where approved and available, participants must have received one or more lines of treatment for advanced/metastatic disease as well as prior endocrine therapy and a CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. If applicable, the requirements for enrollment into a food effect evaluation cohort are the same as the combination cohorts. Part 1 (Safety Expansion) and Part 2 (Dose Expansion) Inclusion Criteria: * Participants with advanced, non-resectable, or metastatic HR+/HER2- BC or PROC, including fallopian tube or primary peritoneal cancer. * PROC participants must have received: * ≥ 1 line of platinum-containing chemotherapy for advanced disease. * ≤ 4 prior therapeutic regimens in the advanced/metastatic setting. * HR+/HER2- BC: * Participants enrolled in regions where CDK4/6 inhibitors are approved and available must have received ≥ 1 line of therapy including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy or ADC treatments for advanced disease. General Inclusion Criteria: * Female participants with advanced or metastatic HR+/HER2- BC will be required to have ovarian function suppression using gonadotropin hormone-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. * Adequate organ function. * For dose escalation, participants with advanced solid tumors other than HR+/HER2- BC must have measurable disease per RECIST 1.1. Participants with HR+/HER2- BC with bone-only disease are eligible for dose escalation only. For safety expansion and dose expansion, all participants must have ≥1 measurable lesion per RECIST v 1.1. General Exclusion Criteria: * For all cohorts: Prior therapy selectively targeting CDK2 inhibition. * For triple combination cohorts: Prior therapy targeting CDK2 or selectively targeting CDK4. Prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available. * Known leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated central nervous system (CNS) metastases may be eligible if they meet additional criteria. * Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, treated papillary thyroid carcinoma, or carcinoma in situ of the cervix or breast). * Uncontrolled diabetes. * Infection requiring systemic antibacterial, antifungal, or antiviral therapy antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection. * Active hepatitis B infection or active hepatitis C infection. * Any major surgical procedure ≤ 28 days before the first dose of study treatment(s). * Prior allogeneic stem cell transplantation, or organ transplantation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Auckland City Hospital
Auckland, 1023, New Zealand
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Avera Cancer Institute
Sioux Falls, South Dakota, 57105-2108, United States
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
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Cancer Research South Australia
Adelaide, South Australia, SA 5000, Australia
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Florida Cancer Specialists and Research Institute
Lake Mary, Florida, 32746-2115, United States
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Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
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Hoag Memorial Presbyterian
Newport Beach, California, 92663-4162, United States
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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Monash Health
Clayton, Victoria, VIC 3168, Australia
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Nepean Hospital
Kingswood, New South Wales, NSW 2747, Australia
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Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
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Rambam Health Care Center
Haifa, 3109601, Israel
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Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, NSW 2010, Australia
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Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
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Shengjing Hospital of China Medical Universityhuaxiang Branch
Shenyang, Liaoning, 110022, China
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Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245, China
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The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
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The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025, Moldova
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Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, 08816-4096, United States
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Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
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