Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors

NCT05142592 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IPG7236-001
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 7

Brief Summary

This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors. The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a). Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.

Conditions

Safety Issues; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Occurrence of all adverse events

  Evaluation of adverse events

  Up to 33 days

• Maximum tolerated dose (MTD）

  MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 33days of multiple dosing.

  Up to 33 days

• Phase II dose (RP2D)

  The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of IPG7236

  Up to 33 days

• Disease Control Rate(DCR)

  Disease Control Rate(DCR) will be determined based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  up to 1 year(anticipated)

Secondary Outcomes (9)

• Maximum plasma concentration（Cmax）

  Up to 33 days

• Time to Cmax (tmax)

  Up to 33 days

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

  Up to 33 days

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

  Up to 33 days

• Apparent terminal phase half-life (t1/2)

  Up to 33 days

Study Arms (6)

Cohort 1

EXPERIMENTAL

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

Drug: IPG7236

Cohort 2

EXPERIMENTAL

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

Drug: IPG7236

Cohort 3

EXPERIMENTAL

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

Drug: IPG7236

Cohort 4

EXPERIMENTAL

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

Drug: IPG7236

Cohort 5

EXPERIMENTAL

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

Drug: IPG7236

Cohort 6

EXPERIMENTAL

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

Drug: IPG7236

Interventions

IPG7236 DRUG

The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A written informed consent must be signed prior to performing any study procedures.
• Male or females 18 years or older.
• Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.
• Part 1 Dose Escalation: all solid tumor types.
• Part 2 Dose Expansion: the following tumor types are tentatively planned for expansion. It may be modified based on the results from the dose escalation phase.
• Renal cancer
• Triple-negative breast cancer
• Head and neck cancer
• Melanoma
• Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds.
• Subjects must demonstrate measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Subjects must have a life expectancy of ≥ 3 months.
• Subjects must have an Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1.
• Subjects must have adequate hematologic and organ function as indicated by the following laboratory values
• Hematologic

You may not qualify if:

• Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.
• Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.
• Subjects with recent prior therapy defined as
• Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
• Any radiotherapy, chemotherapy, targeted therapy or immunotherapy within 14 days or major surgery within 28 days or anti-neoplastic antibody or nitrosoureas/mitomycin C within 42 days prior to the first dose of study drug
• Subjects with any uncontrollable diseases (e.g., severe mental, neurological, cardiovascular, respiratory, and other systemic diseases) or obvious active infections that may affect the clinical study.
• Subjects with positive Coronavirus disease（COVID）-19 PCR tests (patients who recovered from COVID-19 but have positive COVID-19 PCR tests may be included at the judgment of the Investigator)
• Subjects who have received the live or attenuated vaccine within 4 weeks prior to study treatment or intend to receive a live or attenuated vaccine during the study
• 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. History of known HIV infection.
• Note:
• Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) is obtained.
• Subjects with well-controlled HIV may be enrolled if all the following criteria are met:
• must be stable on their anti-retroviral regimen, and participants must be healthy from an HIV perspective
• Participants must have a cluster of differentiation 4（CD4） count of greater than 250 cells/micro litre（mcL ）over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \< 200 cells/mcL over the past 2 years unless it was deemed related to THE CANCER AND/OR CHEMOTHERAPY-induced bone marrow suppression
• \- For patients who have received chemotherapy in the past 6 months, a CD4 count \< 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (7)

Providence Portland Medical Center

Portland, Oregon, 97222, United States

RECRUITING

NEXT Oncology

Austin, Texas, 12221, United States

RECRUITING

The First Affiliated Hospital Nanchang Univeristy

Nanchang, Jiangxi, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shangdong, China

RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

Shanghai General Hospital

Shanghai, China

ACTIVE NOT RECRUITING

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, China

RECRUITING

Central Study Contacts

Filipe Huang

CONTACT

+86 21 34782827; yfhuang@immunophage.com.cn

Yang Hu

CONTACT

+86 21 34782827; yhu@immunophage.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 2, 2021
• Study Start: November 15, 2021
• Primary Completion: September 21, 2025
• Study Completion: December 21, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CN (5)