IPG7236 for Advanced Cancer

Recruiting at 6 trial locations

Overseen By Yang Hu

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, IPG7236, aimed at treating advanced solid tumors. Researchers seek to determine its safety, tolerability, and potential effectiveness in fighting cancer. The study consists of two phases: the first phase tests different doses to identify a safe amount, while the second phase examines its efficacy against specific cancers such as renal, triple-negative breast, head and neck cancers, and melanoma. Individuals with advanced cancer unresponsive to other treatments, who can swallow pills on an empty stomach, might be suitable for this trial. Participants will take the medication twice daily in 28-day cycles, with regular check-ups to monitor their health. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that IPG7236 is likely to be safe for humans?

Research has shown that IPG7236 has been safe in studies so far. In these studies, researchers tested the treatment at doses up to 1000 mg taken twice a day. Importantly, no serious side effects related to the drug were reported at these high doses, suggesting that patients can tolerate the treatment well. Ongoing research aims to understand how the body processes the drug and to determine its effects on tumors. These early findings provide a positive outlook for the safety of IPG7236 in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IPG7236 for advanced cancer because it offers a potentially novel approach to treatment by being administered orally, which is often more convenient and less invasive than traditional intravenous chemotherapy. Unlike many standard cancer treatments that may involve complex regimens and hospital visits, IPG7236 can be taken in pill form, potentially improving patient compliance and quality of life. Additionally, IPG7236's dosing flexibility, ranging from 50 mg to 300 mg twice daily in different cohorts, allows for tailored treatment that can be adjusted to optimize efficacy and minimize side effects. This adaptability and ease of administration make IPG7236 a promising candidate in the evolving landscape of cancer therapies.

What evidence suggests that IPG7236 might be an effective treatment for advanced cancer?

Research has shown that IPG7236 targets a protein called CCR8, which controls immune cells. Studies indicate that this drug can shrink tumors by affecting certain immune cells, specifically Treg and CD8+ T cells, which are crucial for the immune system. In tests with mice that had human breast cancer, IPG7236 significantly slowed tumor growth. These results suggest that IPG7236 could be a promising treatment for advanced cancer by enhancing the body's ability to fight tumors. Participants in this trial will receive different dosages of IPG7236 across various cohorts to evaluate its effectiveness and safety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 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.

I am a man with a partner who can have children and we agree to use birth control.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05142592

Phase1/2a Study for IPG7236 in Patients With Advanced ... This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36988587/

Discovery of a Potent and Selective CCR8 Small Molecular ... IPG7236 is a promising clinical candidate that targets CCR8 with excellent in vitro ADMET properties, pharmacokinetics, safety profiles, and in vivo efficacy.

3. data.niaid.nih.gov data.niaid.nih.gov/resources?id=figshare_22354651

Discovery of a Potent and Selective CCR8 Small Molecular ... IPG7236 demonstrated an anti-cancer effect via modulating Treg and cytotoxic T (CD8+ T) cells. IPG7236 alone or in combination with PD-1 antibody exhibited ...

4. synapse.patsnap.com synapse.patsnap.com/drug/3d57fcc82ea5463ab2f0b025e84c3d93

IPG-7236 - Drug Targets, Indications, Patents IPG7236 alone or in combination with PD-1 antibody exhibited significant tumor suppression effects in the mouse xenograft model of human breast cancer. IPG7236 ...

5. withpower.com withpower.com/trial/phase-1-10-2021-d3cfd

IPG7236 for Advanced Cancer 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 ...

6. axonmedchem.com axonmedchem.com/3962-ipg7236

IPG7236 | CCR8 antagonist | Axon 3962 IPG7236 is a potent, selective and highly bioavailable CCR8 antagonist with IC50 values of 24.0, 24.3 and 33,8 nM for Tango, Ca2+ mobilization and ...

7. pubs.acs.org pubs.acs.org/doi/abs/10.1021/acs.jmedchem.3c00030

Discovery of a Potent and Selective CCR8 Small Molecular ... IPG7236 is a promising clinical candidate that targets CCR8 with excellent in vitro ADMET properties, pharmacokinetics, safety profiles, and in vivo efficacy.

8. immunophage.com.cn immunophage.com.cn/Pipeline/IPG7236

IPG7236-Nanjing Immunophage Biomedical Co., Ltd Superior Safety Profile: In the ongoing Phase 1/2a clinical trial, IPG7236 has been escalated up to 1000 mg BID without any drug-related Serious Adverse Events ...