PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

ProfoundBio

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Nasopharyngeal Carcinoma; Non Hodgkin Lymphoma; Renal Cell Carcinoma

Treatments: Drug: PRO1160

Study type: Interventional

Funder types: Industry

Identifiers

NCT05721222

PRO1160-001

Details and patient eligibility

About

Brief Summary:

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors.

Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC),Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL).

Full description

This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. 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 PRO1160 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 20 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: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma
• Relapsed or refractory disease following prior systemic therapies known to confer medical benefit
• Willing to provide a tumor sample (archive tissue or fresh biopsy)
• ECOG performance status 0 or 1
• Measurable disease per RECIST v1.1 for RCC and NPC and per Lugano for NHL

Exclusion criteria

• Prior treatment with anti-CD70 directed therapy
• Other malignancy within 3 years
• Active CNS metastases (treated, stable CNS metastases are allowed)
• Uncontrolled Grade 3 or greater infection within 2 weeks
• Positive for HBV, HCV or HIV
• Use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
• 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)

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134 participants in 1 patient group

PRO1160

Experimental group

Description:

PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B

Treatment:

Drug: PRO1160