Trial reportInternational journal of clinical oncology2024
Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors.
Trial report in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)
Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- UGT1A1 and Sacituzumab Govitecan Toxicity: A Systematic Review and Meta-Analysis.Clinical pharmacology and therapeutics · 2026Pooled it
- Sacituzumab govitecan as a therapeutic breakthrough in the treatment of triple-negative breast cancer: a systematic review of clinical trials.Frontiers in immunology · 2025Pooled it
- Efficacy and safety of Sacituzumab govitecan in solid tumors: a systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study.Japanese journal of clinical oncology · 2026Trial
- PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; trastuzumab deruxtecan for solid tumors, talazoparib for prostate cancer, sacituzumab govitecan for breast cancer, darolutamide for salivary gland cancer, risovalisib for ovarian cancer, and mosunetuzumab plus polatuzumab vedotin for lymphoma.International journal of clinical oncology · 2026Article
- Overcoming ADC resistance in advanced colorectal cancer by dual targeting of TROP2 and PERK to suppress Wnt/β-catenin signaling.Cell reports. Medicine · 2026Article
- Article
- Bispecific Antibodies in Breast Cancer Immunotherapy: Mechanisms, Advances, and Translational Challenges.Targeted oncology · 2026Review
- Emerging Protein Targets in Triple-Negative Breast Cancer: Beyond Conventional Therapy.Cancers · 2026Review
- A TROP2-targeting ADC synergizes with oxidative phosphorylation inhibitor to enhance apoptosis in ESCC by suppressing the PI3K-AKT-mTOR signaling pathway.Cell death & disease · 2025Article
- The Mode of Action and Clinical Outcomes of Sacituzumab Govitecan in Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved outside Japan for second-line and later metastatic triple-negative breast cancer (mTNBC), based on the ASCENT study (NCT02574455). We report SG safety and efficacy in an open-label, phase 1/2 bridging study in Japanese patients with advanced solid tumors (ASCENT-J02; NCT05101096; jRCT2031210346).
methodsPhase 1 was a standard 3 + 3 design. Patients received intravenous SG 6 mg/kg, escalating to 10 mg/kg, on Days 1 and 8 per 21-day cycle; primary endpoints were safety, incidence of dose-limiting toxicity/toxicities (DLTs), and determination of the recommended phase 2 dose (RP2D). In the multicohort phase 2 study, patients in the mTNBC cohort with previously treated disease received SG at the RP2D; primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR; RECIST v1.1). Safety was a secondary endpoint.
resultsIn phase 1 (N = 15), one DLT (grade 3 elevated transaminases) occurred with SG 10 mg/kg; RP2D was SG 10 mg/kg regardless of UGT1A1 status. In phase 2, 36 patients with mTNBC received SG 10 mg/kg. At median follow-up of 6.1 months, IRC-assessed ORR was 25.0% (95% CI 12.1-42.2; P = 0.0077). Median progression-free survival was 5.6 months (95% CI 3.9-not reached [NR]); median overall survival was NR. No treatment-emergent adverse events led to discontinuation or death.
conclusionsSG RP2D was established as 10 mg/kg in Japanese patients. SG showed efficacy in Japanese patients with previously treated mTNBC, a manageable safety profile, and no new safety signals, consistent with the previous ASCENT study.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.