Actively 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
Led by Shanghai SciBrunch Therapeutics Co., Ltd. · Updated on 2026-02-05
210
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Patients with unresectable, locally advanced or metastatic malignant solid tumors who failed standard therapy or have no standard therapy
- Priority given to breast, ovarian, prostate, or pancreatic cancer patients with homologous recombination deficiency-related gene mutations
- Patients with HER2-negative breast cancer, advanced ovarian/fallopian tube/peritoneal cancer, or castration-resistant prostate cancer with documented BRCA mutation
- Patients with other tumors harboring homologous recombination deficiency-related gene mutations who failed prior standard therapy
- Patients with measurable lesions according to RECIST v1.1
- Tumor tissue and blood samples provided for mutation testing
- ECOG Performance Status 0-1
- Expected survival of at least 3 months
- Adequate organ function including hematopoietic, hepatic, renal, and coagulation parameters
- Patients may be PARP inhibitor pretreated (maximum one prior PARP inhibitor therapy)
- Women of childbearing potential and male patients must agree to use effective contraception
- Signed informed consent form
You will not qualify if you...
- Received systemic anti-tumor therapy within 4 weeks prior to study start (with specific timing exceptions)
- Received radiotherapy within 3 weeks prior or history of radiation pneumonitis
- Received other investigational drugs within 4 weeks prior or 5 half-lives
- Major organ surgery within 4 weeks prior or significant trauma
- Prior treatment with a PARP1 inhibitor (with exceptions in dose-escalation phase)
- Long-term systemic glucocorticoid or immunosuppressive therapy within 14 days prior
- Use of immunomodulatory agents within 14 days prior
- Received live vaccine within 4 weeks prior
- Use of strong CYP3A4 inhibitors or inducers within 7 days prior or during study
- History of bone marrow or solid organ transplantation
- Diagnosis or suspicion of myelodysplastic syndrome or acute myeloid leukemia
- Difficulty swallowing oral medications or malabsorption syndrome
- Unresolved adverse reactions from prior therapy above specified levels
- CNS metastases requiring treatment or unstable
- Severe active infections within 14 days prior
- Positive HIV/AIDS diagnosis
- Active hepatitis B, C, or active syphilis
- Other malignancies within past 3 years except certain treated cancers
- Severe cardiovascular or cerebrovascular diseases
- Severe pulmonary impairment requiring continuous oxygen
- Active or history of autoimmune diseases requiring systemic therapy
- Allergy to study drug components
- Uncontrolled pericardial, pleural effusion, or ascites
- Dementia or altered mental status affecting consent
- Pregnant or lactating women
- Conditions interfering with study participation or compliance
- Other significant risks per investigator judgment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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