A Phase 1 interventional study of ABBV-706 and Cisplatin in Advanced Solid Tumors, sponsored by AbbVie. Active, not recruiting at 66 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's enrollment of 288 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 2 year treatment period.
Drug: ABBV-706
Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 2 year treatment period..
Drug: ABBV-706
Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period.
Drug: ABBV-706 · Drug: Budigalimab
Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.
Drug: ABBV-706 · Drug: Cisplatin · Drug: Carboplatin
Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 2 year treatment period.
Drug: ABBV-706
Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 2 year treatment period.
Drug: ABBV-706
Intravenous (IV) Infusion
Intravenous infusion
IV Infusion
Also known as: ABBV-181
Intravenous infusion
Percentage of Participants With Adverse Events (AE)
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.
Time frame: Up to Approximately 2 Years
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706
Maximum observed serum/plasma concentration of ABBV-706.
Time frame: Up to Approximately 2 Years
Time to Cmax (Tmax) of ABBV-706
Time to Cmax of ABBV-706.
Time frame: Up to Approximately 2 Years
Terminal Phase Elimination Half-Life (t1/2) of ABBV-706
Terminal phase elimination half-life (t1/2) of ABBV-706.
Time frame: Up to Approximately 2 Years
Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706
Area under the serum/plasma concentration-time curve of ABBV-706.
Time frame: Up to Approximately 2 Years
Antidrug Antibodies (ADAs)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to Approximately 2 Years
Neutralizing Antibodies (nAbs)
Incidence and concentration of neutralizing antibodies.
Time frame: Up to Approximately 2 Years
Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors
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.
Time frame: Up to Approximately 2 Years
Recommended Phase 2 Dose (RP2D) of ABBV-706
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.
Time frame: Up to Approximately 2 Years
Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors
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.
Time frame: Up to Approximately 2 Years
Duration of response (DOR) for Participants with Confirmed CR/PR
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.
Time frame: Up to Approximately 2 Years
Percentage of Participants with Clinical Benefit
Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).
Time frame: Up to Approximately 2 Years
Progression-Free Survival (PFS)
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.
Time frame: Up to Approximately 2 Years
Overall survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to Approximately 2 Years
Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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