A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
NCT #
not yet registered
Condition(s)
Non-Small Cell Lung
Molecular Target(s)
AXL & PD1
Drug Classification(s)
Monoclonal Antibody (Immunotherapy, Small Molecule (Targeted), targeted
Agents(s)
AB801
Phase(s)
I
Mechanism of Action
AB801 is an AXL inhibitor
Purpose
• The purpose of the study is to determine whether an experimental drug called AB801 is safe and effective when given alone or in combination with other therapies to patients with the type of cancer you have. • In addition to assessing how safe and well tolerated AB801 is, the study will be measuring the amount of AB801in your bloodstream and monitoring your body’s response to receiving this drug.
- Monotherapy-specific criteria for dose escalation: a. Participants may have cytologically or pathologically confirmed NSCLC, CRC, breast, ovarian, RCC, HNSCC, or bladder carcinoma that has progressed or was nonresponsive to available therapies with no SOC options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
- Disease-specific criteria for dose-expansion Cohort 1 (STK11m [mutated or deleted] NSCLC): a. Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer [AJCC] version 8) nonsquamous NSCLC with documented mutation or deletion in the STK11 gene. b. Negative for actionable mutations including EGFR, anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), mesenchymal-epithelial transition factor (C-MET) or ret proto-oncogene (RET). Mixed small-cell lung carcinoma (SCLC) and squamous NSCLC histology is not permitted. c. Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1 inhibitor.
- Disease-specific criteria for dose-expansion Cohort 2 (NSCLC): a. Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per AJCC version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC histology is not permitted. b. Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1 inhibitor.
- Underlying medical conditions or AEs that, in the investigator’s or sponsor’s opinion, will make the administration of investigational products hazardous, including but not limited to:
- a. Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.
- b. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the Investigational Product, with the exception of prophylactic antibiotic treatment (eg, to prevent a urinary tract infection).
- c. Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable angina or new onset angina within 3 months prior to initiation of study treatment, myocardial infarction within 6 months prior to initiation of study treatment, or unstable arrhythmia.
- d. A condition or unresolved AE from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs.
- e. History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
- f. History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
No restrictions
Location
MCD
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