APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03053466|
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : May 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Microsatellite Instability Mismatch Repair Deficiency Cancer of Unknown Primary Site||Drug: APL-501||Phase 1|
This is a Phase 1, multicenter, 3-part study with a Dose-Escalation Segment, Cohort Extension and Dose and Disease Expansion cohorts of APL-501 injection, a humanized IgG4 monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. Select advanced solid tumor malignancies will receive escalating doses of APL-501.
Dose escalation will occur in three subject cohorts until a protocol defined dose limited toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a tentative maximum tolerated dose (MTD) or biologically effective dose (BED) is determined.
Cohort Extension will evaluate APL-501 at 3 mg/kg and 10 mg/kg on Day 1 and Day 15 every 28 days.
At the tentative MTD, BED or recommended Phase 2 dose (RP2D), at least two tumor types in the Dose and Disease Expansion will be assessed at an equivalent non-weight based dose to further evaluate toxicity and preliminary efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||A Phase 1 Multicenter, Dose Escalation, Cohort Extension and Dose and Disease Expansion Study of APL-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||February 25, 2022|
|Actual Study Completion Date :||February 25, 2022|
Subjects will be assigned to a dose level in the order of study entry. Treatment includes a minimum of four 28-day cycles at three planned dose levels (1, 3, and 10 mg/kg). In the Dose Escalation Segment, each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In the Cohort Extension, the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle.
In Dose and Disease Expansion, the treatment cycle will consist of 2 doses of study drug (non-weight based dosing of 400 mg) administered on Days 1 and 15 of a 28-day cycle.
- Number of participants with treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients with advance solid tumors [ Time Frame: From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months ]Adverse events, serious adverse events, dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)
- Determine the recommended Phase 2 dose and schedule [ Time Frame: An average of 1 year ]adverse events, serious adverse events, dose limiting toxicities
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 4 months (1 cycle = 28 days) ]AUC, 0-infinity
- Maximum plasma concentration [ Time Frame: Up to 4 months (1 cycle = 28 days) ]Cmax
- Time to reach Cmax [ Time Frame: Up to 4 months (1 cycle = 28 days) ]Tmax
- Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]The treatment effect of APL-501 will be assessed by RECIST v1.1 and by irRECIST to determine proportion of patients with complete response or partial response.
- Duration of Response (DOR) [ Time Frame: Approximately 24 months ]The treatment effect of APL-501 will be assessed by RECIST v1.1 or by irRECIST to determine duration of response. Time from first documented complete response or partial response until subsequent documented disease progression or death.
- Time to Response (TTR) [ Time Frame: Approximately 24 months ]The treatment effect of APL-501 will be assessed by RECIST v1.1 and by irRECIST to determine time to complete response and partial response.
- Disease Control Rate (DCR) [ Time Frame: Approximately 24 months ]The treatment effect of APL-501 will be assessed by RECIST v1.1 and irRECIST to determine disease control rate. Proportion of patients with best overall response of complete response, partial response, or stable disease.
- Progression Free Survival [ Time Frame: Approximately 24 months ]The effect of APL-501 will be assessed by RECIST v1.1 and per irRECIST to determine progression free survival as time from date of first dose to date of disease progression or death.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Major Inclusion Criteria:
• Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
- Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junction adenocarcinoma (GC), head and neck (esophageal, hepatocellular (HCC), non-small cell lung cancer, mesothelioma, ovarian, and renal cell carcinoma (RCC), either refractory or relapsed to standard therapy or for which no effective standard therapy is available.
- No restriction to number of prior therapies for Dose Escalation Segment except for gastric and renal cell carcinoma.
- Histologically and/or cytological confirmed solid tumors with an approved labelled indication for PD-1 inhibitors.
- Tumor biopsy at study entry and during therapy. Tumor sites used to satisfy this criterion must not have received any prior radiation therapy. Sites for biopsy must be distinct from target lesions used for efficacy assessment.
- Measurable disease according to RECIST v1.1.
Dose and Disease Expansion:
- MSI-H or dMMR per local laboratory and failed at least one prior line of standard of care chemotherapy per local standards.
- Carcinoma of Unknown Primary
Major Exclusion Criteria:
- History of severe hypersensitivity to mAbs, excipients of the drug product or other components
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
- Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways) (except NSCLC)
- Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the Investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053466
|Australia, New South Wales|
|Chris O'Brien Lifehouse|
|Camperdown, New South Wales, Australia, 2050|
|Cabrini Health Limited|
|Malvern, Victoria, Australia, 3144|
|Peter MaCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3000|
|Melbourne, Victoria, Australia, 3004|
|Australia, Western Australia|
|Linear Clinical Research|
|Nedlands, Western Australia, Australia, 6009|
|Study Director:||Marietta Franco||Apollomics Inc.|
|Responsible Party:||Apollomics (Australia) Pty. Ltd.|
|Other Study ID Numbers:||
|First Posted:||February 15, 2017 Key Record Dates|
|Last Update Posted:||May 9, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Advanced Solid Tumor
Relapsed Solid Tumor
Recurrent Solid Tumor
Neoplasms, Unknown Primary