Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years and Over|
- - Male or non-pregnant, non-lactating female patients age ≥18 years, an exception for MPNST cohort: adolescents ≥12 years old (who weigh at least 40 kg) is allowed.
- - Part 1: 1.
- - Part 2: 1.
- - Life expectancy ≥ 3 months.
- - Continuance of treatment related toxicities (except alopecia) due to prior radiotherapy or chemotherapy agents or biological therapy (including PD-1/PD-L1 antibodies) must be ≤ grade 1 at the time of dosing.
- - Adequate bone marrow and organ function as indicated by the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, red/white blood cell growth factor administration, or albumin infusion) as assessed by laboratory for eligibility.
- - QTcF interval (mean of 3, 1-3 minutes between two tests) ≤450 ms in males and ≤470 ms in females.
- - Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- - Tumor tissue must be provided for all subjects for biomarker analysis before treatment with investigational product.
- - Willingness to use contraception by a method that is deemed effective by the investigator by both male and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
- - Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any screening procedures).
- - Any prior systemic MDM2-p53 inhibitor treatment.
- - Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose.
- - Part 2 Cohort A: Prior loco-regional treatment with intralesional therapy (e.g., talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 weeks prior to start of study treatment.
- - Part 2 Cohort B: Has received radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment.
- - Part 2 Cohort E: Known FGFR translocation mutation.
- - Received hormonal and biologic, small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose.
- - Radiation or surgery within 14 days prior to first dose, thoracic radiation within 28 days prior to first dose.
- - Has known active central nervous (CNS) metastases and/or carcinomatous meningitis.
- - Requirement for corticosteroid treatment (with the exception of megestrol and local use of steroid: i.e., topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
- - Concurrent treatment with an investigational agent or device within 21 days prior to the first dose of therapy.
- - Failure to recover adequately, as judged by the investigator, from prior surgical procedures.
- - Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
- - Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
- - Active infection requiring systemic antibiotic/ antifungal medication, and known clinically active viral infection such as hepatitis B or C, HIV infection, or active COVID-19.
- - Uncontrolled concurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- - Has an active autoimmune disease, or a documented history of autoimmune disease, or a syndrome, that requires systemic steroids or immunosuppressive agents.
- - Has received a live vaccine within 30 days prior to first dose.
- - Has had an allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
- - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- - Has previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) - Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
- - History of organ transplant requiring use of immunosuppressive medication.
- - A woman of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Ascentage Pharma Group Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yifan Zhai, MD, PhD|
|Principal Investigator Affiliation||Ascentage Pharma Group Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, Non Small Cell Lung Cancer, ATM Gene Mutation, P53 Mutation, MDM2 Gene Mutation, Liposarcoma, Urothelial Carcinoma, MPNST, Cutaneous Melanoma, Mucosal Melanoma, Malignant Peripheral Nerve Sheath Tumors, STK11 Gene Mutation|
Part 1 is the open label, dose-escalation phase Ib portion of the study to establish the maximum tolerated dose (MTD)/RP2D of APG-115 in combination with pembrolizumab. Four dose levels of APG-115 will be administered: 50 mg, 100 mg, 150 mg, and 200 mg. APG-115 will be administered orally every other day (QOD) for consecutive 2 weeks and 1 week off dosing as a cycle of 21 days (3 weeks), pembrolizumab will administrated with label dose. Part 2 is a phase II study design, includes cohort A-F six arms. The patients will be treated with APG-115 at 150 mg QOD (RP2D) in combination with pembrolizumab until disease progression, unacceptable toxicity, or another discontinuation criterion is met.
Experimental: APG-115+Pembrolizumab open label, two-part phase Ib/II
single arm dose escalation and dose expansion
Drug: - APG-115+Pembrolizumab
dose escalation of APG-115 in combination with label dose of pembrolizumab, Four dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3-weeks a cycle. Pembrolizumab is administrated following FDA approved label dose, i.e., 200 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.