Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-706: Intravenous (IV) Infusion

Cisplatin: Intravenous infusion

Budigalimab: IV Infusion

Carboplatin: Intravenous infusion

Study summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin.

ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With Adverse Events (AE) — Up to Approximately 2 Years
  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
• Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706 — Up to Approximately 2 Years
  Maximum observed serum/plasma concentration of ABBV-706.
• Time to Cmax (Tmax) of ABBV-706 — Up to Approximately 2 Years
  Time to Cmax of ABBV-706.
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-706 — Up to Approximately 2 Years
  Terminal phase elimination half-life (t1/2) of ABBV-706.
• Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706 — Up to Approximately 2 Years
  Area under the serum/plasma concentration-time curve of ABBV-706.
• Antidrug Antibodies (ADAs) — Up to Approximately 2 Years
  Incidence and concentration of anti-drug antibodies.
• Neutralizing Antibodies (nAbs) — Up to Approximately 2 Years
  Incidence and concentration of neutralizing antibodies.
• Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors — Up to Approximately 2 Years
  Objective response is defined as participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 for for extracranial solid tumors per investigator assessment.
• Recommended Phase 2 Dose (RP2D) of ABBV-706 — Up to Approximately 2 Years
  The RP2D will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures.
• Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors — Up to Approximately 2 Years
  Objective response is as participants achieving a confirmed best overall response of CR and PR according to Response Assessment for Neuro-Oncology (RANO), version 1.1 for CNS tumors per investigator assessment.
• Duration of response (DOR) for Participants with Confirmed CR/PR — Up to Approximately 2 Years
  For participants achieving a confirmed CR/PR, DOR is defined as the time from the initial response of CR/PR to disease progression or death of any cause, whichever occurs earlier.
• Percentage of Participants with Clinical Benefit — Up to Approximately 2 Years
  Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).
• Progression-Free Survival (PFS) — Up to Approximately 2 Years
  PFS is defined as time from first study treatment to a documented disease progression, as determined by the investigator, or death due to any cause, whichever occurs earlier.
• Overall survival (OS) — Up to Approximately 2 Years
  OS is defined as time from first study treatment to death due to any cause.

Trial sites (66)

+ 26 more sites — see the full list on the official registry below.

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