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Study identifier: NCT07359066 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors

Condition: Advanced Solid Tumors · PARP Inhibitor  ·  Sponsor: Shanghai SciBrunch Therapeutics Co., Ltd.

PhasePhase 1/Phase 2
Planned participants210
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is a multicenter, open-label study designed to evaluate SPR1020 in adult patients with advanced solid tumors. The study aims to characterize the safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of SPR1020 monotherapy in this population. The study consists of two parts: Phase I component (dose escalation and backfill) and Phase II component (dose expansion). The primary objectives of the Phase I part are to investigate the safety, tolerability, and PK profile of SPR1020 and to determine the Recommended Phase II Dose (RP2D) and/or the Maximum Tolerated Dose (MTD), if attainable. The Phase II part will be initiated once the RP2D and/or MTD is established in the Phase I part. As a new-generation, highly selective PARP1 inhibitor, SPR1020 demonstrates a competitive clinical benefit-risk profile, combining potential intracranial activity with a differentiated safety profile. By leveraging a "synthetic lethality" mechanism, SPR1020 is expected to demonstrate significant efficacy against tumors harboring BRCA mutations or homologous recombination repair (HRR) pathway gene alterations (e.g., breast cancer, prostate cancer). Owing to its high selectivity for PARP1 over PARP2, SPR1020 may circumvent the hematological toxicities associated with PARP2 inhibition by first-generation pan-PARP inhibitors (e.g., olaparib), potentially resulting in an improved safety profile. This enhanced safety may provide greater flexibility for use in comb…

This description comes directly from the study's public registry record.

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Locations (2)

Cancer Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaNot Yet Recruiting
The Affiliated Tumor Hospital of Harbin Medical UniversityHarbin, Heilongjiang, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07359066