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

Last updated: February 4, 2025
Sponsor: ABL Bio, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ABL503

Clinical Study ID

NCT04762641
ABL503-1001
  • Ages > 18
  • All Genders

Study Summary

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 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically and/or cytologically confirmed diagnosis of any progressive locallyadvanced (unresectable) or metastatic solid tumors that have relapsed or arerefractory following the last line of treatment, for which prior standard therapyhas been ineffective, standard therapy does not exist, or is not consideredappropriate.

  • With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable orirreversible (eg, peripheral neuropathy) from prior therapy that have improved toGrade 1 or the baseline grade more than 14 days prior to the first administration ofthe study drug

  • Adequate hematologic, hepatic, and renal functions confirmed based on the screeninglaboratory tests and reconfirmed with additional safety laboratory tests performedwithin 72 hours prior to the first administration of ABL503

Exclusion

Exclusion Criteria:

  • Prior anticancer monoclonal antibody treatment or investigational therapy within 28days 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 morethan 14 days prior to ABL503 administration

  • Prior chemotherapy or radiation therapy within 2 weeks or targeted small moleculetherapy within 5 half-lives prior to the first administration of study drug or hasnot recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previouslyadministered agent more than 14 days prior to ABL503 administration

  • Requiring or received systemic steroid therapy or any other immunosuppressivetherapy within 14 days prior to study drug administration.

  • Risk factors for bowel obstruction or bowel perforation (including but not limitedto a history of acute diverticulitis, intra-abdominal abscess, and abdominalcarcinomatosis.

  • Discontinued from prior immunomodulatory therapy due to any intolerableimmune-related adverse events (IrAEs) requiring systemic steroid treatment

  • History of drug-induced pneumonitis (interstitial lung disease) or currently haspneumonitis

  • Received prior treatment with an anti-4-1BB antibody

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: ABL503
Phase: 1
Study Start date:
April 01, 2021
Estimated Completion Date:
June 15, 2026

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • USC

    LA, California 90033
    United States

    Active - Recruiting

  • USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCLA

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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