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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

NCT07359066 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-02-05

No results posted yet for this study

Summary

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 combination therapies. Furthermore, SPR1020's ability to penetrate the blood-brain barrier could offer a new treatment option for patients with advanced disease and brain metastases, addressing a high unmet medical need in this population with limited therapeutic choices. Preclinical data support this differentiated profile in terms of both efficacy and toxicity.

Hypothesis: SPR1020 represents a novel anticancer therapeutic with the potential for enhanced efficacy and an improved safety profile. The overall assessment indicates that its clinical benefits outweigh the potential risks.

This study has been approved by the IEC and adheres to the principles of the Declaration of Helsinki.

Conditions

Interventions

DRUG

SRP1020

SPR1020 is administered orally. The dosing frequency is once daily (QD). Each treatment cycle is 21 days.

Sponsors & Collaborators

  • Shanghai SciBrunch Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2028-02-29
Completion
2028-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359066 on ClinicalTrials.gov