PRO1107 in Patients With Advanced Solid Tumors
Purpose
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients 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
- Endometrial Cancer
- Ovarian Cancer
- Triple Negative Breast Cancer
- GastroEsophageal Cancer
- Non-small Cell Lung Cancer
- Urothelial Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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) - Gastric or gastroesophageal junction (GEJ) adenocarcinoma - Esophageal squamous cell carcinoma (ESCC) - Urothelial cancers (bladder, ureter, or renal pelvis) - Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit. Measurable disease at baseline as defined per RECIST, Version 1.1 (Eisenhauer et al. 2009) - Willing to provide a pre-treatment tumor specimen (archival or fresh biopsy samples). - ECOG performance status score 0 or 1.
Exclusion Criteria
- Prior treatment with anti-PTK7 directed therapy. - Had progressive disease as best response while on treatment with an auristatin (vedotin, pelidotin)-based antibody drug conjugate (ADC) as the most recent line of therapy. - Other malignancy within 3 years - Active CNS metastases (treated, stable CNS metastases are allowed) - Uncontrolled infection within 2 weeks. - Positive for HBV, HCV or HIV - Use of a strong P450A CYP3A inhibitor within 2 weeks - Additional protocol defined inclusion/exclusion criteria may apply
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- mTPI
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PRO1107 |
PRO1107 monotherapy in escalating doses in Part A and at the two recommended phase 2 doses in Part B |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Genmab
Detailed Description
This is a Phase 1/2 study of PRO1107, a PTK7 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion. Part A may evaluate up to 7 dose levels of PRO1107 on Day 1 of a 21 day cycle by IV infusion. Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 40 patients per cohort. Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.