Safety IssuesPhase 1/2NCT05142592
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing IPG7236 in people with Safety Issues and Tolerability, run by Nanjing Immunophage Biotech Co., Ltd at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Tolerability, Pharmacokinetics
- What is being tested?
- IPG7236
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Nov 2021to 5 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelet count ≥ 100×109/L
- Hemoglobin ≥ 9 g/dL (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g/dL)
- Renal
- Estimated glomerular filtration rate（eGFR ）≥ 50 mL/min OR serum creatinine ≤ 1.5 × upper limit of normal (ULN).
- Hepatic
- Aspartate aminotransferase levels ≤ 3 ×ULN (if liver metastases are present, ≤ 5× ULN)
- Alanine aminotransferase levels ≤ 2.5 × ULN (if liver metastases are present, ≤ 5×ULN).
- Bilirubin ≤ 1.5 × ULN
- Coagulation • Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN
- Subjects must be able to swallow and retain orally administered medication.
- Patients must be willing and able to comply with all scheduled visits, treatment, laboratory tests, be able to take oral medication, and other requirements of the study
- Female patients of child-bearing potential must have a negative pregnancy test.
- Female patient who is of child-bearing potential is eligible to participate but must use an acceptable form of birth control method, including abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), diaphragm with spermicide, cervical cap, condoms with contraceptive gel/foam /cream, or surgical sterilization (tubal ligation at least 6 months prior to screening) or partner who had a vasectomy at least 6 months prior to screening
- Male patient with a female partner of child-bearing potential is eligible to participate but must be either documented to be surgically sterile (vasectomy), practicing complete abstinence for 90 days after study drug administration, or using two adequate forms of highly effective contraception (together with the female partner), one of which should be a physical barrier method, for 90 days after the study drug administration.
Who cannot join
- 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.
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- 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
- Participants must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of enrollment
- Participants must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts
- Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent may be included at the judgment of the Investigator.
- Subjects with symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >1 month, are asymptomatic and off corticosteroids, or are on a stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. The stability of brain metastases must be confirmed with imaging. The subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post procedure complications or the subject is stable.
- Subjects with active upper digestive tract ulcer or other disorders that can affect drug absorption, distribution, metabolism or clearance.
- Subjects with a marked baseline prolongation of QT/corrected QT interval（QTc） interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (CTCAE grade 1) using Fridericia QT correction formula.
- Subjects using concomitant medications known to prolong the QT/QTc interval.
- Pregnancy or breastfeeding female; Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Subjects who are unable to comply with study and follow-up procedures
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China5 sites
Shandong Cancer Hospital
Jinan, Shangdong
The First Affiliated Hospital Nanchang Univeristy
Nanchang, Jiangxi
Shanghai East Hospital
Shanghai
Shanghai General Hospital
Shanghai
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai
United States2 sites
NEXT Oncology
Austin, Texas, 12221
Providence Portland Medical Center
Portland, Oregon, 97222
About this study
Official title: A Phase 1/2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors
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
- Being tested
- IPG7236
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG7236Drug
The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1~6 subjects in this cohort will receive IPG7236 50 mg bid orally. Receives: Drug: IPG7236 |
| Cohort 2 | Experimental | 3~6 subjects in this cohort will receive IPG7236 100 mg bid orally. Receives: Drug: IPG7236 |
| Cohort 3 | Experimental | 3~6 subjects in this cohort will receive IPG7236 150 mg bid orally. Receives: Drug: IPG7236 |
| Cohort 4 | Experimental | 3~6 subjects in this cohort will receive IPG7236 200 mg bid orally. Receives: Drug: IPG7236 |
| Cohort 5 | Experimental | 3~6 subjects in this cohort will receive IPG7236 250 mg bid orally. Receives: Drug: IPG7236 |
| Cohort 6 | Experimental | 3~6 subjects in this cohort will receive IPG7236 300 mg bid orally. Receives: Drug: IPG7236 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of all adverse events
Evaluation of adverse events
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 1 year(anticipated)
Secondary outcomes (9)
Maximum plasma concentration（Cmax）
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Measured: Up to 33 days
Time to Cmax (tmax)
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Measured: Up to 33 days
Area under the serum concentration-time curve (AUC[0-t]
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Measured: Up to 33 days
Area under the serum concentration-infinity curve AUC[0-infinity]
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Measured: Up to 33 days
Apparent terminal phase half-life (t1/2)
Pharmacokinetic (PK) parameters after a single oral dose of IPG7236
Measured: Up to 33 days
Overall Response Rate (ORR)
the proportion of patients with complete response (CR) and partial response (PR)
Measured: up to 1 year(anticipated)
Duration of response (DoR)
the time from the date when the measurement criteria were met for complete or partial response (whichever occurred first) until the date of the first observed Progression Disease or death as a result of any cause.
Measured: up to 1 year(anticipated)
Progression-free survival (PFS)
the time the patient is enrolled to the date of any recorded disease progression or the death of any cause.
Measured: up to 1 year(anticipated)
Time to Progression(TTP)
the time from clinical remission to disease progression.
Measured: up to 1 year(anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Nov 2021
- Primary completion8 Feb 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142592
- Sponsor's protocol ID
- IPG7236-001
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05142592
- Acronym / sponsor ID
- IPG7236-001
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 8 Feb 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IPG72361~6 subjects in this cohort will receive IPG7236 50 mg bid orally. |
| Cohort 2 | Experimental | Drug: IPG72363~6 subjects in this cohort will receive IPG7236 100 mg bid orally. |
| Cohort 3 | Experimental | Drug: IPG72363~6 subjects in this cohort will receive IPG7236 150 mg bid orally. |
| Cohort 4 | Experimental | Drug: IPG72363~6 subjects in this cohort will receive IPG7236 200 mg bid orally. |
| Cohort 5 | Experimental | Drug: IPG72363~6 subjects in this cohort will receive IPG7236 250 mg bid orally. |
| Cohort 6 | Experimental | Drug: IPG72363~6 subjects in this cohort will receive IPG7236 300 mg bid orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
- 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.
Key exclusion criteria (24 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG7236The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Occurrence of all adverse events
Time frame: Up to 33 days
Evaluation of adverse events
Maximum tolerated dose (MTD）
Time frame: Up to 33 days
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.
Phase II dose (RP2D)
Time frame: Up to 33 days
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
Disease Control Rate(DCR)
Time frame: up to 1 year(anticipated)
Disease Control Rate(DCR) will be determined based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
9 secondary outcomes
Maximum plasma concentration（Cmax）
Time frame: Up to 33 days
Time to Cmax (tmax)
Time frame: Up to 33 days
Area under the serum concentration-time curve (AUC[0-t]
Time frame: Up to 33 days
Area under the serum concentration-infinity curve AUC[0-infinity]
Time frame: Up to 33 days
Apparent terminal phase half-life (t1/2)
Time frame: Up to 33 days
Overall Response Rate (ORR)
Time frame: up to 1 year(anticipated)
Duration of response (DoR)
Time frame: up to 1 year(anticipated)
Progression-free survival (PFS)
Time frame: up to 1 year(anticipated)
Time to Progression(TTP)
Time frame: up to 1 year(anticipated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPG7236 in people with Safety Issues and Tolerability, run by Nanjing Immunophage Biotech Co., Ltd at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of all adverse events (time frame: Up to 33 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.