Actively Recruiting
Open-label Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Adults With Advanced Solid Tumors
Led by Shanghai SciBrunch Therapeutics Co., Ltd. · Updated on 2026-02-05
210
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SPR1020, a new selective PARP1 inhibitor, in adults with advanced solid tumors who have limited treatment options. This open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of SPR1020. The drug is designed to target tumors with BRCA mutations or homologous recombination repair gene alterations, potentially offering improved safety and effectiveness compared to earlier PARP inhibitors, especially for patients with brain metastases. SPR1020 is given orally once daily in 21-day treatment cycles. The study has two main parts: a Phase I dose-escalation and backfill segment to determine the optimal dose and evaluate safety, followed by a Phase II dose-expansion portion to further assess the drug at the recommended dose. Various dose levels from 25 mg to 250 mg per day are being studied. Participants receive the study drug until disease progression or other reasons for treatment end, with the possibility of dose adjustments as needed. Participants will undergo regular monitoring including safety assessments, pharmacokinetic sampling up to about 189 days, and tumor response evaluations using standard criteria. Adverse events will be tracked from the first dose through 30 days after the last dose or until new anti-tumor therapy begins, for up to one year. The study includes frequent lab tests and requires tumor and blood samples for genetic testing. Overall participation can last up to one year, with careful follow-up to evaluate both efficacy and safety outcomes.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic malignant solid tumors
- Patients who have failed standard therapy, have no standard therapy, or are intolerant to standard therapy
- Priority for patients with breast, ovarian, prostate, or pancreatic cancer with homologous recombination deficiency gene mutations such as BRCA1/2, PALB2, or RAD51C/D
- Specific cohorts require confirmed BRCA mutation and prior lines of therapy according to cancer type
- Presence of measurable lesions according to RECIST v1.1
- Willingness to provide tumor tissue and peripheral blood for genetic testing
- ECOG Performance Status of 0-1
- Expected survival time of at least 3 months
- Adequate organ function as defined by blood counts and liver, kidney, and coagulation tests
- Both PARP inhibitor pretreated (max one prior line) and naive patients eligible
- Women of childbearing potential and male subjects must agree to use effective contraception
- Ability to provide informed consent
You will not qualify if you...
- Received systemic anti-tumor therapy within 4 weeks prior to first dose, with specific longer washouts for some agents
- Radiotherapy within 3 weeks prior to treatment, except palliative radiotherapy; history of radiation pneumonitis
- Use of investigational drugs within 4 weeks or 5 half-lives prior to treatment
- Major surgery within 4 weeks prior to treatment
- Prior treatment with a PARP1 inhibitor (with some exceptions in dose escalation phase)
- Use of long-term immunosuppressive therapy or systemic glucocorticoids above specified doses within 14 days prior
- Use of immunomodulatory agents within 14 days prior
- Live or attenuated vaccines within 4 weeks prior
- Use of strong CYP3A4 inhibitors or inducers within 7 days prior or during treatment
- History of bone marrow or organ transplantation
- Diagnosis or suspicion of myelodysplastic syndrome or acute myeloid leukemia
- Difficulty swallowing oral medications or malabsorption syndrome
- Unresolved adverse reactions from prior anti-tumor therapy above grade 1
- Unstable or untreated central nervous system metastases
- Active infections requiring systemic treatment
- Positive HIV, active hepatitis B or C, or active syphilis
- History of other malignancies within past 3 years except certain skin or bladder cancers
- Severe cardiovascular or cerebrovascular disease or poorly controlled hypertension
- Severe pulmonary impairment or need for continuous oxygen
- Active or recurrent autoimmune disease requiring systemic therapy
- Known allergy to study drug components
- Clinically uncontrolled pericardial, pleural effusion, or ascites
- Dementia or altered mental status affecting consent
- Pregnant or lactating women
- Any other significant condition increasing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive SPR1020 orally once daily in repeated 21-day cycles until disease progression or discontinuation.
Visits occur at the start of each 21-day treatment cycle with additional assessments as needed
Duration - 30 days after last dose
Participants are monitored for safety and any adverse events for 30 days after the last dose or until a new anti-tumor therapy begins.
Approximately 1 to 2 visits
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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