A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors
ClinicalTrials.gov processed this data on August 26, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified August 2024 by AbbVie
Sponsor
AbbVieInformation Provided by (Responsible Party)
AbbVieClinicaltrials.gov Identifier
NCT05599984Other Study ID Numbers: M23-385
First Submitted: October 28, 2022
First Posted: October 31, 2022
Last Update Posted: August 27, 2024
Last Verified: August 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 350 participants |
Design Allocation | Non-Randomized |
Interventional Model | Sequential Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors |
Study Start Date | December 5, 2022 |
Anticipated Primary Completion Date | October 15, 2025 |
Anticipated Study Completion Date | May 17, 2027 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | AbbVie |
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Investigators |