PRO1107 in Patients With Advanced Solid Tumors

NCT06171789 | Terminated Phase 1 FDA Drug

• 3 other identifiers: GCT1107-01CTR20242075PRO1107-01
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Endometrial Cancer; Ovarian Cancer; Triple Negative Breast Cancer; GastroEsophageal Cancer; Non-small Cell Lung Cancer; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  Type, incidence, severity, seriousness, and relatedness of adverse events.

  Through end of treatment, up to approximately 1 year

• Number of Participants with Dose Limiting Toxicities (DLTs)

  Incidence of dose limiting toxicities.

  Day 1 up to a maximum of Day 28

Secondary Outcomes (11)

• Objective Response Rate

  Through end of treatment, up to approximately 1 year

• Disease Control Rate

  Through end of treatment, up to approximately 1 year

• Progression-free Survival

  Up to approximately 18 months

• Duration of Objective Response

  From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months

• Pharmacokinetic Parameter Area Under the Curve (AUC) for GEN1107

  Varying timepoints through end of treatment, up to approximately 1 year

Study Arms (1)

GEN1107

EXPERIMENTAL

GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.

Drug: GEN1107

Interventions

GEN1107 DRUG

IV infusion of GEN1107

GEN1107

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (7)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START Mountain Cancer Center

Salt Lake City, Utah, 78229, United States

Location

Institution of Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Modified toxicity probability interval (mTPI)

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 15, 2023
• Study Start: January 3, 2024
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CN (1)