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PRO1107 in Patients With Advanced Solid Tumors

P

ProfoundBio

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

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

Treatments

Drug: PRO1107

Study type

Interventional

Funder types

Industry

Identifiers

NCT06171789
PRO1107-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

214 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

214 participants in 1 patient group

PRO1107
Experimental group
Description:
PRO1107 monotherapy in escalating doses in Part A and at the two recommended phase 2 doses in Part B
Treatment:
Drug: PRO1107

Trial contacts and locations

4

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Central trial contact

ProfoundBio Trial Support

Data sourced from clinicaltrials.gov

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