PRO1107 in Patients With Advanced Solid Tumors (NCT06171789) | Clinical Trial Compass
TerminatedPhase 1/2
PRO1107 in Patients With Advanced Solid Tumors
Stopped: Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation
United States, China33 participantsStarted 2024-01-03
Plain-language summary
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Part A:
* Pathologically confirmed diagnosis of one of the following tumor types:
* Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)
* Endometrial cancer (any subtype excluding sarcoma)
* Triple negative breast cancer (TNBC)
* Non-small cell lung cancer (NSCLC)
* Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit.
Part B:
* Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy as specified below:
* Ovarian cancer
* TNBC
* Endometrial cancer
* NSCLC
* Measurable disease at baseline as defined per RECIST, Version 1.1
Exclusion Criteria
* Prior treatment with anti-PTK7-directed therapy.
* Had progressive disease as best response while on treatment with an auristatin (eg, a vedotin or pelidotin)- based ADC as the most recent line of therapy.
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%)
* Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events
Timeframe: Through end of treatment, up to approximately 1 year
2
Number of Participants with Dose Limiting Toxicities (DLTs)