Description:
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose,
dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD
and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503
in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors
who are relapsed or refractory following the last line of treatment and have no available
standard of care option. This study includes 2 parts: a dose-escalation part and a
dose-expansion part.
Title
- Brief Title: This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects With Any Progressive Locally Advanced or Metastatic Solid Tumors
- Official Title: A Phase 1 Dose Escalation and Expansion Study of ABL503, a Bispecific Antibody of 4-1BB and PD-L1, as a Single Agent in Subjects With Any Progressive Locally Advanced (Unresectable) or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
ABL503-1001
- NCT ID:
NCT04762641
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ABL503 | | ABL503 |
Purpose
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose,
dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD
and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503
in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors
who are relapsed or refractory following the last line of treatment and have no available
standard of care option. This study includes 2 parts: a dose-escalation part and a
dose-expansion part.
Trial Arms
Name | Type | Description | Interventions |
---|
ABL503 | Experimental | ABL503 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically and/or cytologically confirmed diagnosis of any progressive locally
advanced (unresectable) or metastatic solid tumors that have relapsed or are
refractory following the last line of treatment, for which prior standard therapy has
been ineffective, standard therapy does not exist, or is not considered appropriate.
- With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable or
irreversible (eg, peripheral neuropathy) from prior therapy that have improved to
Grade 1 or the baseline grade more than 14 days prior to the first administration of
the study drug
- Adequate hematologic, hepatic, and renal functions confirmed based on the screening
laboratory tests and reconfirmed with additional safety laboratory tests performed
within 72 hours prior to the first administration of ABL503
Exclusion Criteria:
- Prior anticancer monoclonal antibody treatment or investigational therapy within 28
days prior to the first administration of study drug or has not recovered (ie, ≤ Grade
1 or at baseline grade) from AEs due to previously administered agent more than 14
days prior to ABL503 administration
- Prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule
therapy within 5 half-lives prior to the first administration of study drug or has not
recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previously administered
agent more than 14 days prior to ABL503 administration
- Requiring or received systemic steroid therapy or any other immunosuppressive therapy
within 14 days prior to study drug administration.
- Risk factors for bowel obstruction or bowel perforation (including but not limited to
a history of acute diverticulitis, intra-abdominal abscess, and abdominal
carcinomatosis.
- Discontinued from prior immunomodulatory therapy due to any intolerable immune-related
adverse events (IrAEs) requiring systemic steroid treatment
- History of drug-induced pneumonitis (interstitial lung disease) or currently has
pneumonitis
- Received prior treatment with an anti-4-1BB antibody
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Subjects with Dose-Limiting Toxicities (DLT) |
Time Frame: | From Day 1 until disease progression or Day 28, whichever came first |
Safety Issue: | |
Description: | Number of subjects with Dose-Limiting Toxicity (DLT) |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
Safety Issue: | |
Description: | Proportion of subject with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 |
Measure: | Pharmacokinetic (PK) of ABL503 |
Time Frame: | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
Safety Issue: | |
Description: | Serum concentrations of ABL503 will be collected and analyzed to evaluate the PK of ABL503 |
Measure: | Immunogenicity of ABL503 |
Time Frame: | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
Safety Issue: | |
Description: | Incidence of anti-ABL503 antibody will be analyzed to evaluate the Immunogenicity of ABL503 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ABL Bio, Inc. |
Last Updated
July 23, 2021