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Advanced Solid TumorsPhase 1/2NCT07359066

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

A Phase 1/2 study testing SRP1020 in people with Advanced Solid Tumors and PARP Inhibitor, run by Shanghai SciBrunch Therapeutics Co., Ltd. at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, PARP Inhibitor
What is being tested?
SRP1020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
13 sitesChina
Study dates
8 Jan 2026to Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjets ≥ 18 years old.
  • Phase I Dose-Escalation Part: Patients with histologically or cytologically confirmed, surgically unresectable, locally advanced or metastatic malignant solid tumors, who have experienced failure of standard therapy, or for whom no standard therapy exists, or who are intolerant to standard therapy. (Priority will be given to enrolling patients with breast, ovarian, prostate, or pancreatic cancer harboring homologous recombination deficiency (HRD)-related gene mutations such as BRCA1/2, PALB2, RAD51C/D).
  • Phase I Dose Backfill Portion: Patients with HER2-negative breast cancer (BC), advanced epithelial ovarian cancer (OC)/fallopian tube cancer (FTC)/primary peritoneal cancer (PPC), or castration-resistant prostate cancer (CRPC), who have a documented pathogenic or likely pathogenic BRCA mutation (BRCAm, germline or somatic) as detected by a local or central laboratory, and who have experienced failure of at least one prior line of standard anticancer therapy (refer to the protocol section for the Phase II dose expansion for specific standard therapy requirements); Or patients with other tumor types harboring homologous recombination deficiency (HRD) related gene mutations (including but not limited to esophageal cancer, small cell lung cancer, or pancreatic cancer) who have experienced failure of at least one prior line of standard therapy.
  • Phase II Dose Expansion Study: Allows prior treatment with a pan-PARP inhibitor (no more than 1 type). Specific requirements for each cohort are as follows:
  • Cohort 1: Breast Cancer (BC):
  • Histologically or cytologically confirmed HER2-negative (HR+/HER2- or triple-negative) advanced or metastatic breast cancer.
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  • Presence of a predicted loss-of-function BRCA1/2 mutation in germline or tumor tissue.
  • Received at least > 1 line of systemic therapy for advanced disease (must have received at least one line of chemotherapy; if HR+, must have received endocrine therapy), with recent radiological confirmation of disease progression.
  • Cohort 2: Ovarian Cancer (OC):
  • Histologically confirmed high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Presence of a predicted loss-of-function BRCA1/2 mutation in germline or tumor tissue.
  • Received at least > 1 line of systemic therapy for advanced disease (must have received at least one platinum-based chemotherapy regimen for advanced disease), with recent radiological confirmation of disease progression.
  • Subjects must have a response duration of ≥ 6 months after the last platinum-based chemotherapy (platinum-sensitive population).
  • Cohort 3: Prostate Cancer (PC):
  • Histologically or cytologically confirmed prostatic adenocarcinoma, which has progressed to the castration-resistant stage.
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analog or status post bilateral orchiectomy, with serum testosterone < 50 ng/dL (< 1.73 nmol/L) within 28 days prior to study enrollment. Patients receiving ADT at the time of enrollment should continue this therapy throughout the study period.
  • Presence of a predicted loss-of-function BRCA1/2 mutation in germline or tumor tissue.
  • Received at least > 2 lines of systemic therapy for advanced disease (must have received a novel hormonal agent [NHA] and chemotherapy), with recent radiological confirmation of disease progression.
  • Cohort 4:
  • 1) The aforementioned tumor types (from Cohorts 1-3) harboring HRRm (excluding BRCA mutations), or other tumor types harboring HRRm (including but not limited to esophageal cancer, small cell lung cancer, or pancreatic cancer, etc.), which have failed after first-line or later standard therapy.
  • 3. Presence of at least one measurable lesion according to RECIST v1.1. 4. For both Phase I backfill and Phase II expansion, patients must provide tumor tissue (archived specimen from within 12 months pre-ICF preferred; fresh biopsy if unavailable) and peripheral blood for BRCAm/HRRm testing. Provision of specimens is also encouraged for Phase I dose-escalation patients when feasible. Testing will be conducted at a Sponsor-designated central laboratory. The samples provided shall comply with the following requirements:
  • Option 1 : 8-10 sections of surgically resected tumor tissue specimens, or 10-15 sections of core needle biopsy specimens; fine needle aspiration specimens are not acceptable; plus approximately 2 mL of peripheral blood.
  • Option 2 : If tumor tissue samples cannot be provided, a peripheral blood sample of approximately 10 mL may be provided instead.
  • Note:BRCAm/HRRm results must meet eligibility criteria. A prior positive local laboratory report is acceptable for enrollment without awaiting central lab results; the central report will serve for retrospective validation. If sample quantity is insufficient, Sponsor consultation is required for enrollment eligibility.
  • 5. ECOG Performance Status of 0-1. 6. Expected survival time ≥ 3 months. 7. Adequate organ function:
  • Hematopoietic system (Has not received blood transfusion or hematopoietic growth factor therapy within 14 days): i. Platelet count ≥ 100 × 10^9/L ii. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L iii. White blood cell count ≥ 3.0 × 10^9/L iv. Hemoglobin ≥ 90 g/L b. Hepatic function: i. Total bilirubin ≤ 1.5 × ULN ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (in the absence of liver metastases) iii. ALT and AST ≤ 5.0 × ULN (In subjects with liver metastases) c. Renal function: i. Creatinine clearance (Ccr) > 50 mL/min (calculated by the Cockcroft-Gault formula) d. Coagulation function: i. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN ii. International normalized ratio (INR) ≤ 1.5 × ULN 8. Both PARPi-pretreated and PARPi-naive patients are eligible for enrollment. For PARPi-pretreated patients, they are allowed to have received a maximum of one prior line of PARPi-containing therapy (whether as monotherapy or as maintenance therapy).
  • 9. Women of childbearing potential (WOCBP) (defined as those not surgically sterile or from menarche until 1 year after menopause) must have a negative serum pregnancy test result within 7 days prior to the first dose of the IP. WOCBP must agree to practice abstinence or use highly effective contraceptive methods from the time of signing the informed consent form until 3 months after the last dose of the IP. Similarly, male subjects (including those post-vasectomy) must agree to use effective contraception or practice abstinence from the time of signing the informed consent until 3 months after the last dose of the IP, and must refrain from sperm donation during this period.
  • 10. The subject must provide informed consent for the study prior to any trial-related procedures and voluntarily sign the written informed consent form.

Who cannot join

  • Have received systemic anti-tumor therapy (including chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to the first dose of the investigational product, with the following specifics: mitomycin and nitrosoureas within 6 weeks from the last dose; oral fluorouracil drugs (such as tegafur and capecitabine) within 2 weeks from the last dose; small molecule targeted agents within 2 weeks or 5 half-lives from the last dose, whichever is shorter; have received any herbal or botanical products with purported anti-tumor effects within 2 weeks prior to the first dose of the investigational product.
  • Have received radiotherapy (with the exception of palliative radiotherapy) within 3 weeks prior to the initiation of study treatment, or have a history of radiation pneumonitis. Note: With the exception of a history of radiation pneumonitis, subjects must have recovered from all radiation-related toxicities.
  • Have received other unapproved investigational drugs within 4 weeks prior to the first dose of the investigational product, or within 5 half-lives of the other drug(s), whichever is shorter.
  • Have undergone major organ surgery (excluding Puncture Biopsy) within 4 weeks prior to the first dose of the investigational product, or have experienced significant trauma, or require elective surgery during the trial period.
  • Prior treatment with a PARP1 inhibitor. Note: For subjects enrolling in the dose-escalation phase, enrollment may be considered following discussion with and agreement from the sponsor's medical representative.
  • Have received or are anticipated to require long-term systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of the investigational product. The following are exceptions: topical, intra-articular, intranasal, and inhaled corticosteroids; corticosteroid administration as premedication for contrast-enhanced imaging studies to prevent allergic reactions; short-term (≤ 7 days) use of corticosteroids for the prevention or treatment of non-autoimmune allergic conditions; and glucocorticoids used during the treatment stage for castration-resistant prostate cancer (CRPC).
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  • Have used immunomodulatory agents, including but not limited to thymic peptides, interleukin-2 (IL-2), interferon, etc., within 14 days prior to the first dose of the investigational product.
  • Have received a live or attenuated live vaccine within 4 weeks prior to the first dose of the investigational product. Inactivated vaccines are permitted.
  • Have used within 7 days prior to the first dose of the investigational product or require concomitant use during the study treatment period of medications, herbal supplements, or foods known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (refer to Appendix 4 a summary list of common CYP3A4 enzyme inducers and inhibitors).
  • Have a prior history of allogeneic bone marrow transplantation or solid organ transplantation.
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or presenting with features suggestive of MDS/AML.
  • Have difficulty swallowing oral medications, or have malabsorption syndrome or any other poorly controlled gastrointestinal disease that may affect bioavailability.
  • Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, hyperpigmentation, and other tolerable events judged by the investigator) or to the level specified in the protocol inclusion/exclusion criteria.
  • Patients with central nervous system (CNS) metastases meeting any of the following criteria: (a) requiring local therapy (surgery, radiotherapy, or other); (b) CNS metastases requiring or currently being treated with corticosteroids at a dose >10 mg prednisone or equivalent; (c) unstable CNS metastases or a stability duration of less than 14 days after the last treatment prior to enrollment; (d) presence of spinal cord compression or leptomeningeal metastasis.
  • Presence of severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose (including tuberculosis infection).
  • Have a known history of a positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
  • Patients with active hepatitis B (if hepatitis B surface antigen is positive, HBV-DNA testing is required; subjects with positive HBsAg and HBV-DNA > 500 copies/mL or > 100 IU/mL are considered to have active hepatitis B and must be excluded). Subjects who test positive for HBV-DNA may be enrolled if, after receiving antiviral therapy, their HBV-DNA level decreases to below the lower limit of detection for ≥ 2 weeks, and they must continue to receive antiviral therapy during the study period; patients with hepatitis C (if the HCV antibody test is positive, HCV-RNA testing is required; subjects with a positive HCV antibody test and a positive HCV RNA result are considered to have hepatitis C and must be excluded); patients with active syphilis (if the Treponema pallidum antibody test is positive, an antibody titer test is required; patients with active syphilis should be excluded according to the central laboratory's testing standards).
  • History of other malignancies within the past 3 years, except for adequately treated basal cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix.
  • Have a history of severe cardiovascular or cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, QTcF interval ≥ 470 ms, etc.
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose of the investigational product.
  • For patients with chronic cardiac disease, New York Heart Association (NYHA) functional class > II or left ventricular ejection fraction (LVEF) < 50%.
  • Poorly controlled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite clinical therapy.
  • History of severe hemorrhage or thrombotic diseases within 6 months prior to the investigational product administration, or use of anticoagulants (such as warfarin) or similar agents requiring therapeutic International Normalized Ratio (INR) monitoring.
  • Have clinically significant severe pulmonary impairment, including but not limited to infectious pneumonia or requiring continuous supplemental oxygen to maintain adequate oxygenation.
  • Subjects with active autoimmune disease, or a history of autoimmune disease that may recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, autoimmune thyroid disease), or subjects with related risks (e.g., those who have undergone organ transplantation requiring immunosuppressive therapy). Subjects with skin diseases that do not require systemic therapy (e.g., vitiligo, psoriasis) may be enrolled.
  • Known hypersensitivity or allergy to any component of the investigational product.
  • Clinically uncontrolled pericardial effusion, pleural effusion, or ascites requiring repeated drainage.
  • Have dementia or altered mental status that may affect the understanding and provision of informed consent.
  • Pregnant or lactating women.
  • Have underlying disease conditions (including laboratory abnormalities), or alcohol/drug abuse or dependence, which may interfere with the administration of the investigational product, affect the interpretation of drug toxicity or adverse events, or lead to inadequate or reduced compliance with study procedures.
  • Any other significant condition that, in the judgment of the investigator, would substantially increase the risk associated with the patient's participation in the study, or affect the patient's ability to receive the investigational product or complete the study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

China13 sites, 13 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Fei Ma, 13910217780, 13910217780@139.com

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Jing Luo, 18981838521, jingluopi@163.com

    Recruiting

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan

    Qingli Li, 18180609168, liqingli73@163.com

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Yanxia Shi, 13609058827, shiyx@sysucc.org.cn

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Xian Wang, 15857121122, wangxian@srrsh.com

    Recruiting

  • The Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Li Cai, 13313602929, caiwenxin76@163.com

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Fanfan Li, 13855137365, 693671174@qq.com

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong

    Meili Sun, 18953116532, sunli1980@163.com

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

    Tao Sun, 13940404526, lnzlrxnsy@163.com

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Jing Yao, 13971139665, Jeaneyph@163.com

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Jin Yang, 18991232383, 1473106133@gq.com

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Yanhua Liu, 18952171926, 37813965@gg.com

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Min Yan, 15713857388, ym200678@126.com

    Recruiting

Other trials in China

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.

Read more

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.

Being tested
SRP1020
Keywords
SPR1020

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRP1020Drug

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

Study groups in NCT07359066
Study groupRoleWhat they receive
25mg/dayExperimentalNot described
Receives: Drug: SRP1020
50mg/dayExperimentalNot described
Receives: Drug: SRP1020
100mg/dayExperimentalNot described
Receives: Drug: SRP1020
150mg/dayExperimentalNot described
Receives: Drug: SRP1020
200mg/dayExperimentalNot described
Receives: Drug: SRP1020
250mg/dayExperimentalNot described
Receives: Drug: SRP1020

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT/MTD

    Incidence and characteristics of Dose-Limiting Toxicity (DLT) to determine the Maximum Tolerated Dose (MTD).

    Measured: Within 24 days after the first dose (including 3 days of Cycle 0 and 21 days of Cycle 1)

  2. RP2D

    Recommended Phase II Dose (RP2D) of SPR1020, as the dose for efficacy study in Phase II, will be the dose with promising clinical responses observed in the patients, and well tolerated by patients.

    Measured: From the first dose until disease progresses or end of treatment for other reasons，up to 1 year

  3. Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)

    Incidence and characteristics of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period, were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

    Measured: All AEs/SAEs (including irAEs/AESIs) will be collected from first dose until 30 days after the last dose, or until new anti-tumor therapy begins，up to 1 year

Secondary outcomes (15)

  1. ORR

    Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR and other efficacy evaluation indexes are based on RECIST 1.1 criteria

    Measured: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first，up to 1 year

  2. DCR

    Disease control rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD).

    Measured: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first，up to 1 year

  3. DOR

    Duration of Response (DOR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) or death from any cause.

    Measured: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first，up to 1 year

  4. PFS

    Progression-Free Survival (PFS) is the time between first initiation of study treatment to PD or death due to any reason.

    Measured: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first，up to 1 year

  5. OS

    Overall Survival (OS) is defined as the time interval from the date of the first dose of study drug to the date of death from any cause.

    Measured: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first，up to 1 year

  6. Cmax

    Peak concentration (Cmax).

    Measured: Up to approximately 189 days(Cycle 9 Day 1，a cycle for 21 days)

  7. Tmax

    Peak time (Tmax).

    Measured: Up to approximately 189 days(Cycle 9 Day 1，a cycle for 21 days)

  8. t1/2

    Elimination phase half-life (t1/2).

    Measured: Up to approximately 189 days(Cycle 9 Day 1，a cycle for 21 days)

  9. AUC0-t

    Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t).

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days)

  10. AUC0-∞

    Area under plasma concentration-time curve from 0 to infinite time (AUC0-∞)

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days)

  11. AUC0-last

    Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration.

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days)

  12. CL

    Clearance

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days )

  13. Vd

    Volume of Distribution

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days)

  14. F

    Bioavailability

    Measured: Up to approximately 189 days(Cycle 9 Day 1, a cycle for 21 days)

  15. PARylation

    Poly(ADP-ribosyl)ation

    Measured: Up to approximately 15 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start8 Jan 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07359066
Sponsor's protocol ID
SPR1020-S-001
Status last verified
Jan 2026
First submitted
16 Dec 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SRP1020 in people with Advanced Solid Tumors and PARP Inhibitor, run by Shanghai SciBrunch Therapeutics Co., Ltd. at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT/MTD (time frame: Within 24 days after the first dose (including 3 days of Cycle 0 and 21 days of Cycle 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07359066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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