Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-706 · 3 trials · 2 indications
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by BICR assessment prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the percentage of participants achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI).
OS is defined as the time from the date of randomization to the date of death of any cause.
An AE is defined as 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.
PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first.
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 of ABBV-706.
Time to Cmax of ABBV-706.
Terminal phase elimination half-life (t1/2) of ABBV-706.
Area under the serum/plasma concentration-time curve of ABBV-706.
Incidence and concentration of anti-drug antibodies.
Incidence and concentration of neutralizing antibodies.
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.
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.
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.
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.
Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).
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.
| Arm | Type | Description |
|---|---|---|
| ABBV-706 | EXPERIMENTAL | Participants will receive ABBV-706 as part of the 53 month study duration. |
| Stand of Care (SOC) | ACTIVE_COMPARATOR | Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration. |
| Safety Lead-In: ABBV-706 Dose A | EXPERIMENTAL | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Safety Lead-In: ABBV-706 Dose B | EXPERIMENTAL | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Safety Lead-In: Stand of Care (SOC) | EXPERIMENTAL | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
| Expansion: ABBV-706 Dose A | EXPERIMENTAL | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Expansion: ABBV-706 Dose B | EXPERIMENTAL | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Expansion: SOC | EXPERIMENTAL | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
| Part 1: ABBV-706 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 2 year treatment period. |
| Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion | EXPERIMENTAL | 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.. |
| Part 3a: ABBV-706 + Budigalimab | EXPERIMENTAL | Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period. |
| Part 3b: ABBV-706 + Platinum Chemotherapy | EXPERIMENTAL | Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period. |
| Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors | EXPERIMENTAL | 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. |
| Part 4b: ABBV-706 Monotherapy Dose Expansion NECs | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| ABBV-706 | DRUG | Intravenous (IV) Infusion |
| Topotecan | DRUG | IV Infusion |
| Lurbinectedin | DRUG | IV Infusion |
| Amrubicin | DRUG | IV Infusion |
| Atezolizumab | DRUG | IV Infusion |
| Etoposide | DRUG | IV Infusion |
| Carboplatin | DRUG | IV Injection |
| Cisplatin | DRUG | Intravenous infusion |
| Budigalimab | DRUG | IV Infusion |
Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC). * Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as: * In the 1L and 2L setting respectively, p...
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ABBV-706 is an investigational small molecule being developed by AbbVie for the treatment of advanced solid tumors and small cell lung cancer. It is currently being studied in clinical trials for these indications, including as a first-line treatment for extensive stage small cell lung cancer and for relapsed or refractory small cell lung cancer.
The molecular target of ABBV-706 has not been disclosed in available information. It is described as a small molecule therapeutic being evaluated in oncology clinical trials for advanced solid tumors and small cell lung cancer, but its specific mechanism of action has not been publicly detailed.
ABBV-706 is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors and small cell lung cancer.
ABBV-706 is in clinical development across multiple phases. It is being studied in a Phase 1 trial for advanced solid tumors, a Phase 2 trial for extensive stage small cell lung cancer, and a Phase 3 trial for relapsed or refractory small cell lung cancer. It is not yet approved by regulatory authorities.
ABBV-706 is being evaluated in three clinical trials. NCT05599984 is a Phase 1 study in advanced solid tumors. NCT07155174 is a Phase 2 study in previously untreated extensive stage small cell lung cancer. NCT07365241 is a Phase 3 study in relapsed or refractory small cell lung cancer.
Yes, ABBV-706 is being studied alone and in combination with other agents. In the Phase 1 trial, it is given with budigalimab, cisplatin, or carboplatin. In the Phase 2 trial, it is combined with atezolizumab and compared to standard of care.