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Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors

NCT06819215RecruitingPHASE1, PHASE2INTERVENTIONAL

Summary

This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Key Facts

Lead Sponsor

Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Enrollment

188

Start Date

2024-10-30

Completion Date

2025-12-30

Study Type

INTERVENTIONAL

Official Title

Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors

Interventions

VB15010

Conditions

CancerNeoplasmsNeoplasmsBreastTumorPARPOvarian NeoplasmsProstatic CancerPancreatic CancerBreast CancerBiliary CancerColorectal Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

ALL

Inclusion Criteria:

* Age ≥ 18 at the time of screening;
* Histological or cytological confirmation of advanced malignancy ;
* Progressive cancer at the time of study entry;
* Adequate organ and marrow function as defined by the protocol;
* Homologous recombination repair gene mutation.

Exclusion Criteria:

* Major surgery within 4 weeks of the ﬁrst dose of study treatment.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

Outcome Measures

Primary Outcomes

The number of subjects with adverse events/serious adverse events

Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline

Time frame: From time of Informed Consent to 30+7 days post last dose

The number of subjects with dose-limiting toxicity (DLT), as deﬁned in the protocol.

A DLT is defined as any toxicity that occurs from the ﬁrst dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.

Time frame: At the end of Cycle 1(each cycle is 28 days)

Secondary Outcomes

Maximum plasma concentration of the drug (Cmax)

The concentration of VB15010 in plasma will be determined (Cmax will be derived)

Time frame: At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)

Objective Response Rate (prostate cancer)

Best response until progression, as deﬁned by RECIST 1.1 or PCWG3 (bone)

Time frame: From Screening to conﬁrmed progressive disease (approximately 1 year)

Locations

Cancer Hospital of Shandong First Medical university, Jinan, China

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.