PRJ1-3024 for Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new oral medicine, PRJ1-3024, on patients with advanced solid tumors that have not responded to other treatments. The study aims to find a safe dose and see if the medicine can shrink or stop tumor growth.

Eligibility Criteria

Adults (≥18 years) with advanced solid tumors that are untreatable by standard therapies or when such treatments aren't suitable. Participants must have a measurable tumor, be able to take oral meds and track their use, have a life expectancy over 3 months, and proper organ function. They should not have other cancers, significant heart disease, active hepatitis or HIV infections, recent live vaccines, autoimmune diseases on immunosuppressants, or current cancer treatments.

Inclusion Criteria

My advanced cancer has no standard treatment options left.

I can take care of myself and am up and about more than half of my waking hours.

I can take pills and am willing to track my medication use daily.

Exclusion Criteria

I am not taking any cancer treatments, trial drugs, or specific enzyme inhibitors.

I need more than 10 mg/day of prednisolone for my brain metastases.

I have a serious heart condition.

I have not received a live vaccine in the last 30 days.

I have had another type of cancer in the past.

I have an active autoimmune disorder or am on immunosuppressive therapy.

I have not been treated with HPK1 inhibitors before.

I do not have active hepatitis B, hepatitis C, or AIDS.

Participant Groups

The trial is testing PRJ1-3024's safety and early effectiveness in patients with relapsed/refractory solid tumors. It's an open-label study where everyone gets the drug; doses increase until they find the highest dose patients can safely take without severe side effects ('dose escalation').

1Treatment groups

Experimental Treatment

Group I: Monotherapy EscalationExperimental Treatment1 Intervention

3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.