PRO1160 for Advanced Cancer

Recruiting at 32 trial locations

Overseen By Glenn Michelson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ProfoundBio US Co.

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Other malignancy, Active CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

134 Participants Needed

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.

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.

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

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+