Study on PRO1107 for Patients with Advanced Solid Tumors

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06171789

Provider View

This clinical trial is testing a new drug, PRO1107, to see if it is safe and effective in treating various advanced solid tumors, including certain types of breast, lung, and ovarian cancers. The study is divided into two parts to determine the best dose and to see how well the drug works against specific tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment called PRO1107 for patients with advanced solid tumors, such as ovarian, endometrial, and certain types of breast and lung cancers. The trial is divided into two parts: the first part tests different doses to find the safest and most effective one, while the second part focuses on how well the drug works on specific types of tumors.

Description

The trial is testing a new drug called PRO1107, which is designed to target cancer cells in patients with advanced solid tumors. These include ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. The study is divided into two main parts:

  • Part A: Dose Escalation - This part tests up to seven different doses of PRO1107 to find the safest and most effective dose. The drug is given through an IV infusion every 21 days.

  • Part B: Dose Expansion - Once the best dose is determined from Part A, this part will test the drug in up to four groups of patients, with up to 40 patients in each group, to see how well it works against specific types of tumors.

Patients will continue to receive the treatment until their cancer progresses, they experience unacceptable side effects, the doctor decides to stop the treatment, they choose to withdraw, the study ends, they become pregnant, or they pass away.

Eligibility Criteria

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

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.