RNK05047 for Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

Must not be taking: Anticancer therapy

Disqualifiers: CNS metastases, HIV, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests RNK05047, a new drug, on patients with advanced solid tumors, including DLBCL. The drug is given regularly through an IV to find the safest and most effective dose.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot be on any concurrent anticancer therapy. You must wait for at least 5 half-lives of any prior systemic cancer therapy before starting the study drug.

Eligibility Criteria

This trial is for adults with advanced solid tumors or diffuse large B-cell lymphoma who've run out of standard treatment options. They must be in fairly good health, understand the study, and agree to use effective birth control. Pregnant women, those with certain infections like HIV or hepatitis, and people with unresolved side effects from past cancer treatments can't join.

Inclusion Criteria

Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.

My liver, kidneys, blood, and clotting functions are all within normal ranges.

I agree to use effective birth control during and for 4 months after treatment.

+7 more

Exclusion Criteria

I might have cancer spread to my brain or spinal cord.

I had cancer before but was treated with the goal of curing it.

I experience significant numbness or pain in my hands or feet.

+4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle, following a 3+3 design

4 weeks per cycle

3 visits (in-person) per cycle

Cohort Expansion

Additional subjects are enrolled to receive RNK05047 at the established RP2D, with tumor types determined based on prior data

Varies by cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing RNK05047 given through an IV to see if it's safe and works against advanced cancers. It has two parts: first finding the right dose (dose escalation) and then giving that dose to more people (cohort expansion).

1Treatment groups

Experimental Treatment

Group I: RNK05047Experimental Treatment1 Intervention

Dose-escalation of RNK05047 IV infusion