Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer

Summary: This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB928 in combination with carboplatin/pemetrexed with or without pembrolizumab and AB122 monotherapy in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).

Detailed description: Dose escalation of AB928 in combination with carboplatin/pemetrexed and AB928 in combination with carboplatin/pemetrexed plus pembrolizumab at standard doses will be assessed in participants with advanced metastatic non-squamous Non-Small Cell Lung Cancer. In this dose escalation combination study, participants will receive oral administration of AB928 as well as IV infused carboplatin/pemetrexed with or without pembrolizumab.
  Dose expansion of AB928 in combination with carboplatin/pemetrexed and AB928 in combination with carboplatin/pemetrexed plus pembrolizumab at standard doses may be assessed in participants with advanced metastatic non-squamous Non-Small Cell Lung Cancer. The dose of AB928 used will be determined based on the findings from the dose escalation phase.
  Concurrently, AB122 monotherapy will be assessed in participants with advanced non-squamous Non-Small Cell Lung Cancer.
  Overall duration of treatment will depend on how well the treatment is tolerated.
  Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

Eligibility: Inclusion Criteria:
  1. Male or female participants; age ≥ 18 years
  2. Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression.
  3. Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  5. Confirm that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor lesion must be obtained.
  6. Prior chemotherapy or immunotherapy or biologic agents must have been completed at least 4 weeks before IP administration.
  7. Adequate organ and marrow function
  Exclusion Criteria:
  1. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
  2. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product(s) hazardous
  3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  4. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of investigational product for non-PD-1-containing regimens and through 90 days after the last dose of investigational products for PD-1-containing regimens.
  5. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
  6. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
  7. Prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 4 weeks prior to Day 1 or has not recovered (ie, ≤ Grade 1 or baseline) from AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy and other AEs considered not clinically significant by the Medical Monitor and Investigator.
  8. Prior use of an adenosine pathway targeting agent.
  9. Participants who are eligible for potentially curative available therapies or interventions.
  10. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.

Relevance to patient case: not relevant