PRO1160 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: ProfoundBio US Co.

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Other malignancy, Active CNS metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests PRO1160, a targeted cancer treatment, in patients with advanced or hard-to-remove cancers. PRO1160 uses an antibody to find cancer cells and a drug to kill them.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use a strong P450 CYP3A inhibitor within 14 days before starting the trial.

Research Team

Eligibility Criteria

This trial is for adults with advanced cancers like kidney cancer, nasopharyngeal cancer, or stage III/IV non-Hodgkin's lymphoma that have worsened after treatment. Participants must be able to provide a tumor sample and should not have had certain other cancers in the last 3 years or been treated with anti-CD70 therapy.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer is advanced and cannot be surgically removed.

You are willing to give a sample of your tumor, either from a previous biopsy or a new one.

Exclusion Criteria

I have not had any other cancer in the last 3 years.

I haven't had a severe infection in the last 2 weeks.

I have been treated with anti-CD70 therapy before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Evaluation of up to 7 dose levels of PRO1160 on Day 1 of a 21-day cycle by IV infusion

21 days per cycle, multiple cycles

Dose Expansion (Part B)

Initiation at a dose level based on analysis from Part A in up to 4 different cohorts

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months

Treatment Details

Interventions

• PRO1160 (Other)

Trial Overview PRO1160 is being tested on participants with solid tumors or liquid cancers that are metastatic or unresectable. The study has two parts: Part A determines the best dose and schedule of PRO1160; Part B assesses its safety and effectiveness at the determined dose against specific types of cancer.

Participant Groups

Group I: PRO1160 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

ProfoundBio US Co.

Lead Sponsor

Trials

3

Recruited

750+