What side effects are associated with this type of intervention?

Common treatments similar to IPG7236, such as tyrosine kinase inhibitors (e.g., pazopanib), often have side effects that include significant hypertension, diarrhea, and hepatotoxicities. For instance, pazopanib has been associated with grade 2 or greater hypertension in 52% of patients, grade 3 or 4 diarrhea in 8%, and grade 3 or 4 hepatotoxicities in 9%. Other side effects of TKIs can include fatigue, neutropenia, and various cardiovascular effects. These side effects are important considerations when evaluating the safety and tolerability of anti-tumor agents.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for their anti-tumor activity and have undergone extensive pharmacokinetic studies. For instance, pembrolizumab, an immune checkpoint inhibitor, has been approved for various cancers including melanoma and renal cell carcinoma, with studies demonstrating its efficacy and safety at different dosing schedules. Similarly, vemurafenib, a BRAF inhibitor, has shown significant activity in treating BRAF-mutant cancers such as hairy cell leukemia. These drugs, like IPG7236, have been evaluated in clinical trials to determine their optimal dosing, safety, and efficacy in treating advanced tumors.

What other types of research exist?

Promising novel alternatives to IPG7236 for anti-tumor activity include: 1) Niraparib plus nivolumab or niraparib plus ipilimumab for platinum-sensitive advanced pancreatic cancer, 2) Elotuzumab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma, 3) Pembrolizumab monotherapy for advanced clear cell renal cell carcinoma, and 4) Relatlimab and nivolumab combination for untreated advanced melanoma. These therapies have shown efficacy and safety in recent clinical trials and may be considered for treatment in 2024.

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IPG7236 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Nanjing Immunophage Biotech Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable

Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1

Must not have

Subjects with previous malignant disease within the last 3 years

Pregnancy or breastfeeding female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year(anticipated)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for IPG7236 aren't listed, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to low blood counts, liver issues (elevated enzymes), kidney function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can carry out all my usual activities without help.

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My blood and organ tests meet the required health standards.

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I can swallow and keep down pills.

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I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or breastfeeding.

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I do not have a primary brain tumor, HIV-related cancer, or cancer from an organ transplant.

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I am taking medication that affects my heart's rhythm.

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I have brain or spinal cord cancer that is causing symptoms or hasn't been treated.

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I have been diagnosed with HIV.

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I do not have active ulcers or disorders affecting drug processing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year(anticipated)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year(anticipated)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year(anticipated) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate(DCR)

Maximum tolerated dose (MTD）

Occurrence of all adverse events

+1 more

Secondary study objectives

Apparent terminal phase half-life (t1/2)

Area under the serum concentration-infinity curve AUC[0-infinity]

Area under the serum concentration-time curve (AUC[0-t]

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 6Experimental Treatment1 Intervention

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

Group II: Cohort 5Experimental Treatment1 Intervention

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

Group III: Cohort 4Experimental Treatment1 Intervention

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

Group IV: Cohort 3Experimental Treatment1 Intervention

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

Group V: Cohort 2Experimental Treatment1 Intervention

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

Group VI: Cohort 1Experimental Treatment1 Intervention

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments in pharmacokinetics for anti-tumor activity include tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. TKIs, such as pazopanib, work by blocking specific enzymes (tyrosine kinases) involved in the signaling pathways that promote cancer cell growth and survival. Monoclonal antibodies, like pembrolizumab, target specific proteins on cancer cells or immune cells to enhance the body's immune response against tumors. Understanding these mechanisms is crucial for pharmacokinetics patients as it helps in optimizing drug dosing, minimizing side effects, and improving therapeutic efficacy by tailoring treatments to individual patient profiles.

Population-based meta-analysis of bortezomib exposure-response relationships in multiple myeloma patients.