HB0036 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Active CNS metastases, Autoimmune disease, Active infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called HB0036 in patients with advanced solid tumors, including NSCLC. The goal is to determine if the drug is safe and effective in treating these cancers.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, certain conditions like recent use of antibiotics, corticosteroids, or anticancer therapies may affect eligibility, so it's best to discuss your specific medications with the trial team.

Research Team

Yang Yang, MD/PHD

Principal Investigator

Shanghai Huaota Biopharmaceutical Co., Ltd.

Eligibility Criteria

Adults with advanced solid tumors, measurable cancer lesions, good performance status (able to carry out daily activities), and proper organ function can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent severe allergic reactions to similar drugs, certain heart conditions within the past 6 months, active infections like HIV or hepatitis B/C, other recent treatments or trials, substance abuse issues.

Inclusion Criteria

I am fully active or can carry out light work.

At least one measurable lesion as per RECIST v. 1.1

My cancer is advanced, recurrent, or has spread to other parts.

See 8 more

Exclusion Criteria

I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception during the trial.

I agree to use birth control during and for 3 months after treatment.

I have been treated with medication targeting the TIGIT pathway.

See 23 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Evaluation of safety and tolerability of HB0036 in patients with advanced solid tumors

21 days

1 visit every 3 weeks

Phase II Treatment

Evaluation of safety and efficacy of HB0036 at the RP2D in cohorts of patients with NSCLC and/or other solid tumors

Up to 24 months

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

HB0036 (Other)

Trial OverviewThe study is testing HB0036's safety and effectiveness in treating advanced solid tumors including non-small cell lung cancer. It's an early-phase trial assessing how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), and its potential benefits.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: HB0036Experimental Treatment1 Intervention

HB0036 IV every 3 weeks (q3w)