Clinical trial · Interventional
PRO1107 in Patients With Advanced Solid Tumors
A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors
NCT06171789CI-TRIAL-00113056terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| GastroEsophageal Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEN1107 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GEN1107
- description
- GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.
- interventionNames
- Drug: GEN1107
Primary outcomes (2)
- measure
- Number of Participants with Adverse Events
- timeFrame
- Through end of treatment, up to approximately 1 year
- description
- Type, incidence, severity, seriousness, and relatedness of adverse events.
- measure
- Number of Participants with Dose Limiting Toxicities (DLTs)
- timeFrame
- Day 1 up to a maximum of Day 28
- description
- Incidence of dose limiting toxicities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of NSCLC or breast cancer should have a computed tomography (CT)/ magnetic resonance imaging (MRI) scan of the brain at screening. * Participants with active or chronic corneal disorders, history of corneal transplantation, or any clinically significant corneal disease that prevents adequate monitoring of potential drug-induced keratopathy. Note: Participants with other active ocular conditions requiring ongoing therapy and/or monitoring must be discussed with the sponsor prior to enrollment. Additional protocol defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.