NHL, AdultPhase 1/2NCT05186012
APG-1252 Monotherapy or in Combination With Other Therapeutic Agent in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1/2 study testing APG-1252 and Chidamide in people with NHL, Adult, run by Ascentage Pharma Group Inc. at 4 sites in China.
Trial summary
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL, Adult
- What is being tested?
- APG-1252 and Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesChina
- Study dates
- 14 Jun 2022to 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
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Corrected QT interval (QTcB or QTcF ) ≤ 450ms (male), or ≤ 470ms (female).
- Patients with relapsed/refractory NHL in Part 1 (excluding Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma or primary central nervous system lymphoma) and relapsed/refractory PTCL in Part 2, previously treated with at least 1 prior line of therapy.
- Patients must have an adequate bone marrow function.
- Adequate hepatic, renal and coagulation function.
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- Male and female subjects of childbearing potential who agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study drug.
- Ability to understand and voluntarily sign a written informed consent form before performing any study procedures.
- Compliance to study procedures.
Who cannot join
- Prior history of allogeneic cell transplant, adoptive cellular immunotherapy within 2 years, or autologous hematopoietic stem cell transplantation within 6 months prior to the first dose.
- Monoclonal antibody therapy within 4 weeks prior to the first dose.
- Received anti-cancer therapy within 14 days prior to the first dose of therapy, including chemotherapy, radiotherapy, immunotherapy or hormone therapy for anti-tumor purposes; or 28 days for any investigational agent prior to the first dose of therapy.
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
- Not recovered from recent surgical procedures based on investigator's discretion. Major surgical procedure within ≤28 days or minor surgical procedure (excluding biopsy) within ≤14 days prior to initiating study treatment.
- Prior exposure to BCL-xL inhibitor. Subjects who have been treated with chidamide can still be included in the study unless they were intolerant.
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- Intolerant to other Bcl-2 family protein inhibitors.
- Has known central nervous system (CNS) involvement or the prior history of primary central nervous system lymphoma.
- Prior history of cardiovascular disease ≥ grade 2 (New York Heart Association grade 2 cardiovascular disease is defined as that the patient feels comfortable at rest, but ordinary physical activities lead to fatigue, palpitation, dyspnea or angina pectoris). Unstable angina, myocardial infarction, or coronary revascularization within 180 days prior to the first dose.
- Use of therapeutic doses of anti-coagulants is an exclusion, including anti-platelet agents. Use of low-dose anticoagulation medications to maintain the patency of a central intravenous catheter is permitted. Aspirin taken within 1 week before the first dose is an exclusion.
- Known bleeding diathesis/disorder. Recent history of non-chemotherapy induced thrombocytopenia associated a major bleeding episode or a history of being refractory to platelet transfusions within 1 year prior to the first dose. Gastrointestinal bleeding or active peptic ulceration within 3 months prior to the first dose. Active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA).
- A potentially bleeding condition or the presence of clinically significant bleeding signs.
- Known to be allergic to the drug component or its analogues.
- Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
- Within 3 years before entering the study, the subject had a history of active malignant tumors other than NHL, except that: Fully treated cervical carcinoma in situ; Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Confinement and resection of previously cured malignancies (or other treatment).
- Uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to Covid-19 RNA positive, HBV-SURFACE antigen positive and HBV-DNA≥2,000 copies/mL or ≥500 IU/ mL; Hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive.
- A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him / her.
- Uncontrolled other clinically significant symptoms, including but not limited to uncontrolled serious infection, febrile neutropenia occured within 1 week before administration. Symptomatic congestive heart failure, unstable angina, arrhythmia, or social environment that may affect study compliance.
- Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Jiangsu Province Hospital
Nanyang
Li Wang, M.D.
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Rong Tao, M.D., hkutao@hotmail.com
- Recruiting
Shanghai Jiao Tong University school of medicine Ruijin Hospital
Shanghai
Weili Zhao, M.D., zwl_trial@163.com
- Not yet recruiting
Henan Provincial Oncology Hospital
Zhengzhou, Henanan
Yanyan Liu, M.D.
About this study
Official title: A Phase Ib/II Study of APG-1252 as a Single Agent or in Combination With Other Therapeutic Agent in Patients With Relapsed and/or Refractory Non-Hodgkin Lymphoma(NHL)
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL.
Read the detailed description
This is an open-label, multi-center Phase Ib/II study of safety, PK, PD and efficacy of APG-1252 as a single agent in relapsed/refractory NHL or in combination with chidamide in relapsed/refractory peripheral T cell lymphomas (PTCL) patients. The primary objective is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD) and the recommended dose (RP2D) of APG-1252 monotherapy or in combination with chidamide in relapsed/refractory PTCL patients.
This study consists of two parts: The first part is the APG-1252 single agent cohort, including dose escalation phase with a standard 3+3 design and dose expansion phase with 6-15 patients at MTD dose level. The second part is the APG-1252 plus chidamide, including dose escalation phase with a standard 3+3 design and dose expansion phase with 9-12 patients at MTD dose level.
Patients will be treated in 28-day cycles. APG-1252 will be administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22). Chidamide will be administered 30mg orally BIW. All subjects will continue to receive treatment until disease progression, unacceptable toxicities, or other treatment discontinuation criteria defined by the protocol.
- Conditions
- NHL, Adult
- Being tested
- APG-1252, Chidamide
- Keywords
- APG-1252
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-1252Drug
Also called Pelcitoclax
APG-1252 administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22).Every 28 days as a cycle.
ChidamideDrug
Chidamide 30mg orally BIW. Every 28 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Single agent) | Experimental | Not described Receives: Drug: APG-1252 |
| Arm B (combo) | Experimental | Not described Receives: Drug: APG-1252; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 28 days of study treatment. These will be assessed via CTCAE version 5.0.
Measured: 28 days
Maximally tolerated dose (MTD)
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Jun 2022
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHL, AdultStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifan Zhai, MD, PhD, Study chair, Ascentage Pharma Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186012
- Sponsor's protocol ID
- APG1252LC101
- Status last verified
- Aug 2023
- First submitted
- 23 Dec 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of APG-1252 as a Single Agent or in Combination With Other Therapeutic Agent in Patients With Relapsed and/or Refractory Non-Hodgkin Lymphoma(NHL)
- ClinicalTrials.gov ID
- NCT05186012
- Acronym / sponsor ID
- APG1252LC101
- Conditions
- NHL, Adult
- Keywords
- APG-1252
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 Jan 2022 (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.
The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-1252 single agent and in combination with other therapeutic agent in patients with NHL.
Detailed description
This is an open-label, multi-center Phase Ib/II study of safety, PK, PD and efficacy of APG-1252 as a single agent in relapsed/refractory NHL or in combination with chidamide in relapsed/refractory peripheral T cell lymphomas (PTCL) patients. The primary objective is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD) and the recommended dose (RP2D) of APG-1252 monotherapy or in combination with chidamide in relapsed/refractory PTCL patients.
This study consists of two parts: The first part is the APG-1252 single agent cohort, including dose escalation phase with a standard 3+3 design and dose expansion phase with 6-15 patients at MTD dose level. The second part is the APG-1252 plus chidamide, including dose escalation phase with a standard 3+3 design and dose expansion phase with 9-12 patients at MTD dose level.
Patients will be treated in 28-day cycles. APG-1252 will be administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22). Chidamide will be administered 30mg orally BIW. All subjects will continue to receive treatment until disease progression, unacceptable toxicities, or other treatment discontinuation criteria defined by the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Single agent) | Experimental | Drug: APG-1252 |
| Arm B (combo) | Experimental | Drug: APG-1252, Drug: Chidamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Corrected QT interval (QTcB or QTcF ) ≤ 450ms (male), or ≤ 470ms (female).
- Patients with relapsed/refractory NHL in Part 1 (excluding Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma or primary central nervous system lymphoma) and relapsed/refractory PTCL in Part 2, previously treated with at least 1 prior line of therapy.
- Patients must have an adequate bone marrow function.
Key exclusion criteria (19 listed)
- Prior history of allogeneic cell transplant, adoptive cellular immunotherapy within 2 years, or autologous hematopoietic stem cell transplantation within 6 months prior to the first dose.
- Monoclonal antibody therapy within 4 weeks prior to the first dose.
- Received anti-cancer therapy within 14 days prior to the first dose of therapy, including chemotherapy, radiotherapy, immunotherapy or hormone therapy for anti-tumor purposes; or 28 days for any investigational agent prior to the first dose of therapy.
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
- Not recovered from recent surgical procedures based on investigator's discretion. Major surgical procedure within ≤28 days or minor surgical procedure (excluding biopsy) within ≤14 days prior to initiating study treatment.
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 |
|---|---|---|
| APG-1252Also: PelcitoclaxAPG-1252 administered via intravenous infusion for 30 minutes weekly (Day 1, 8, 15, 22).Every 28 days as a cycle. | Drug | Arm A (Single agent), Arm B (combo) |
| ChidamideChidamide 30mg orally BIW. Every 28 days as a cycle. | Drug | Arm B (combo) |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 28 days
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 28 days of study treatment. These will be assessed via CTCAE version 5.0.
Maximally tolerated dose (MTD)
Time frame: 28 days
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
Yifan Zhai, MD, PhD study chair
Ascentage Pharma Group Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APG-1252 and Chidamide in people with NHL, Adult, run by Ascentage Pharma Group Inc. at 4 sites in China.
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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, MD. (13512112076, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: 28 days). The study lists 2 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 23 Jan 2024.