IPG7236 for Advanced Cancer

Recruiting at 6 trial locations

Overseen By Gewen Tan

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nanjing Immunophage Biotech Co., Ltd

Must not be taking: QT prolonging drugs

Disqualifiers: CNS malignancy, HIV-related cancer, others

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

Compensation: Varies

Number of Visits: 2

196 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, IPG7236, in patients with advanced solid tumors to see if it is safe and can help shrink their tumors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken any investigational or FDA-approved anti-cancer drugs within 14 days or 5 half-lives before the first dose of the study drug, or if you have had recent radiotherapy, chemotherapy, or certain other treatments. It's best to discuss your specific medications with the study team.

Eligibility Criteria

Adults with advanced solid tumors that are metastatic or unresectable, who have not responded to standard treatments or cannot tolerate them. They must be able to take oral medication and commit to the study's schedule. Women of childbearing potential and men with partners of childbearing potential must use effective contraception.

Inclusion Criteria

I am 18 years old or older.

I have tried all standard cancer treatments without success, or I cannot tolerate them.

My cancer is advanced or has come back, cannot be surgically removed, and has spread.

Exclusion Criteria

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

Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Dose Escalation

Participants receive escalating doses of IPG7236 to determine the maximum tolerated dose

4 weeks per cycle

Weekly visits (in-person)

Dose Expansion

Participants receive the recommended Phase 2 dose of IPG7236 to evaluate safety and anti-tumor activity

4 weeks per cycle

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• IPG7236

Trial Overview The trial is testing IPG7236, an oral drug for advanced solid tumors. It includes two phases: dose escalation to find a safe dosage and dose expansion to further assess safety and effectiveness. Patients will take the drug twice daily on an empty stomach in continuous 28-day cycles.

Participant Groups

Group I: Cohort 6 Experimental Treatment 1 Intervention

3\~6 subjects in this cohort will receive IPG7236 300 mg bid orally.

Group II: Cohort 5 Experimental Treatment 1 Intervention

3\~6 subjects in this cohort will receive IPG7236 250 mg bid orally.

Group III: Cohort 4 Experimental Treatment 1 Intervention

3\~6 subjects in this cohort will receive IPG7236 200 mg bid orally.

Group IV: Cohort 3 Experimental Treatment 1 Intervention

3\~6 subjects in this cohort will receive IPG7236 150 mg bid orally.

Group V: Cohort 2 Experimental Treatment 1 Intervention

3\~6 subjects in this cohort will receive IPG7236 100 mg bid orally.

Group VI: Cohort 1 Experimental Treatment 1 Intervention

1\~6 subjects in this cohort will receive IPG7236 50 mg bid orally.

Who Is Running the Clinical Trial?

Nanjing Immunophage Biotech Co., Ltd

Lead Sponsor

Trials

6

Recruited

490+