--- title: A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors nct_id: NCT05234606 overall_status: WITHDRAWN phase: PHASE1, PHASE2 sponsor: Silverback Therapeutics study_type: INTERVENTIONAL primary_condition: Urothelial Carcinoma canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05234606.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05234606" ct_last_update_post_date: 2022-04-12 last_seen_at: "2026-05-12T06:40:48.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors **Official Title:** A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression **NCT ID:** [NCT05234606](https://clinicaltrials.gov/study/NCT05234606) ## Key Facts - **Status:** WITHDRAWN - **Why Stopped:** Sponsor decision based on strategic re-alignment - **Phase:** PHASE1, PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 0 - **Lead Sponsor:** Silverback Therapeutics - **Conditions:** Urothelial Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Hormone Receptor-positive/HER2-negative Breast Cancer - **Start Date:** 2022-03 - **Completion Date:** 2022-03-31 - **CT.gov Last Update:** 2022-04-12 ## Brief Summary This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression. ## Detailed Description This is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and preliminary antitumor activity of SBT6290 administered subcutaneously (SC) as a monotherapy and in combination with pembrolizumab in solid tumors associated with Nectin-4 expression. There are 4 parts to this study: * Part 1: A dose escalation of SBT6290 monotherapy * Part 2: Tumor-specific expansion cohorts evaluating SBT6290 monotherapy administered at the recommended phase 2 dose (RP2D) identified in Part 1 * Part 3: A dose escalation of SBT6290 in combination with pembrolizumab * Part 4: An expansion cohort of SBT6290 in combination with pembrolizumab administered at the RP2D identified in Part 3 for the combination ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Key Inclusion Criteria: * Locally advanced or metastatic solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer) * Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria * Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria * ECOG Performance Status of 0 or 1 * Adequate organ and marrow function Note: Other protocol-defined inclusion/exclusion criteria may apply. Key Exclusion Criteria: * History of allergic reactions to certain components of study treatments * Untreated brain metastases * Currently active (or history of) autoimmune disease * Taking the equivalent of \>10 mg / day of prednisone * Uncontrolled or clinically significant interstitial lung disease (ILD) * History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living * HIV infection, active hepatitis B or hepatitis C infection Note: Other protocol-defined inclusion/exclusion criteria may apply. ``` ## Arms - **Part 1: SBT6290** (EXPERIMENTAL) — SBT6290 every 3 weeks - **Part 2: SBT6290** (EXPERIMENTAL) — SBT6290 every 3 weeks - **Part 3: SBT6290 + pembrolizumab** (EXPERIMENTAL) — SBT6290 plus pembrolizumab every 3 weeks - **Part 4: SBT6290 + pembrolizumab** (EXPERIMENTAL) — SBT6290 plus pembrolizumab every 3 weeks ## Interventions - **SBT6290** (DRUG) — Escalating doses by subcutaneous (SC) injection in 21-day cycles - **SBT6290** (DRUG) — Dose expansion with the recommended Phase 2 dose (RP2D) by SC injection in 21-day cycles - **pembrolizumab** (DRUG) — 200 mg via intravenous (IV) injection in 21-day cycles ## Primary Outcomes - **Number of Participants With Dose Limiting Toxicities: Part 1 and Part 3** _(time frame: Up to 28 days after the first dose of SBT6290)_ — Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. - **Number of Participants With Treatment-emergent Adverse Events: All Parts** _(time frame: From enrollment to 30 days after the last dose of SBT6290, up to 2 years)_ — Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. - **Number of Participants With an Objective Response Rate: Part 2 and Part 4** _(time frame: From enrollment to confirmed response, up to 1 year)_ — Complete response and partial response as assessed by RECIST Version 1.1 Criteria. - **Duration of Response for Participants With an Objective Response Rate: Part 2 and Part 4** _(time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years)_ — Complete response and partial response as assessed by RECIST Version 1.1 Criteria. ## Secondary Outcomes - **Number of Participants With an Objective Response Rate: Part 1 and Part 3** _(time frame: From enrollment to confirmed response, up to 1 year)_ - **Duration of Response for Participants With an Objective Response Rate: Part 1 and Part 3** _(time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years)_ - **Rate of Disease Control for Participants: All Parts** _(time frame: Up to at least 6 months after the first dose of SBT6290)_ - **Progression-free Survival: Part 2** _(time frame: From first dose of SBT6290 until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years)_ - **Estimates of Selected PK Parameters for SBT6290: All Parts** _(time frame: Immediately before and after SBT6290 doses up to 2 years)_ - **Estimates of Selected PK Parameters for SBT6290: All Parts** _(time frame: Immediately before and after SBT6290 doses up to 2 years)_ - **Incidence of SBT6290 Antidrug Antibodies (ADA): All Parts** _(time frame: Immediately before and after SBT6290 doses for up to 2 years)_ ## Recent Field Changes (last 30 days) - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05234606.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05234606* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*