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Advanced Solid TumorPhase 1/2NCT06078670

PARP Inhibitor CVL218 in Combination Therapy for Patients With Advanced Solid Tumors

A Phase 1/2 study testing CVL218 in people with Advanced Solid Tumor, run by Fujian Cancer Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the efficacy of CVL218 in combination with Toripalimab injection/Sintilimab injection (Darbersol, Sintilimab) in the treatment of advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
CVL218
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
No sites listed yet
Study dates
10 Oct 2023to Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients between the ages of 18 and 75 (including those aged 18 and 75, and those over 60 years old should not suffer from more than 3 complications of heart, lung, liver and kidney function at the same time), regardless of gender.
  • 2. Patients with locally advanced or metastatic advanced solid tumors confirmed by histology or cytology (including but not limited to triple-negative breast cancer, gastric cancer, colorectal cancer); Patients with ≤1 line of standard treatment failure (disease progression after treatment or intolerability of toxic side effects of treatment), or no standard treatment, or unable to receive standard treatment.
  • 3. In stage II, patients with positive PD-L1 molecular expression level combined with CPS≥1 were required to be enrolled, or there was evidence of harmful HRD gene variants (BRCA1, BRCA2, PALB2, ATM, CHEK2 variants, etc.).

Who cannot join

  • Chemotherapy, radiotherapy, biotherapy and endocrinology were received within 4 weeks before the first administration
  • Treatment, immunotherapy and other antitumor drugs, except the following:
  • Nitrosourea or mitomycin C within 6 weeks before first use of the study drug;
  • Oral fluorouracil and small molecule targeted drugs are used before first investigational drugs
  • 2 weeks or within 5 half-lives of the drug, whichever is longer;
  • Traditional Chinese medicines with anti-tumor indications were used within 2 weeks before the first use of study drugs.
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  • 2. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to initial administration
  • Therapy.
  • 3. Received major organ surgery (excluding puncture) within 4 weeks prior to initial administration
  • Biopsy) or significant trauma.
  • 4. Received systemic glucocorticoids (strong) within 14 days prior to initial administration
  • Pine > 10mg/ day or equivalent dose of similar drugs) or other immunosuppressant
  • Treatment;
  • Except in the following cases: topical, ocular, intraarticular, intranasal, and inhalation
  • Type I glucocorticoid therapy; Short-term use of corticosteroids for prophylactic treatment (eg to prevent contrast allergy).

About this study

Official title: Phase Ib/II Clinical Study of PARP Inhibitor CVL218 in Combination With Therapy in Patients With Advanced Solid Tumors

This study aims to evaluate the efficacy of CVL218 in combination with Toripalimab injection/Sintilimab injection (Darbersol, Sintilimab) in the treatment of advanced solid tumors. It focuses on assessing the safety, tolerability, and pharmacokinetic profile of a three-drug combination regimen comprising albumin-bound paclitaxel injection (Kealil), paclitaxel injection (Taxol), and Fuquinitinib capsule (Aiutec, Fruquintinib).

Read the detailed description

This Phase Ib/II clinical study is designed to determine the recommended Phase II dosage of the combination therapy and its initial efficacy. The study consists of two phases: an exploratory phase (Ib) and an extended phase (II), each divided into three stages: the screening period, treatment period, and follow-up period.

The screening period occurs 28 days prior to the first dose administration. Three parallel queues were organized, with Phase Ib enrolling 3-6 participants per dose level cohort and Phase II enrolling approximately 20 participants per cohort.

In Phase II, subjects must demonstrate evidence of deleterious HRD gene variants (such as BRCA1, BRCA2, PALB2, ATM, CHEK2 variants) or a positive PD-L1 molecular expression level combined score (CPS) of ≥1. Additionally, Phase II participants are required to consent to the provision of sufficient archived or fresh tumor tissue and blood samples for biomarker analysis in the central laboratory, including determination of HRD gene mutation status and PD-L1 expression level (details in Section 7.4).

During the treatment period, the three cohorts received CVL218 orally (PO) in combination with a fixed dose of either terriplizumab injection (Toripalimab) or Sintilimab injection (Darbersol, Sintilimab). Additionally, they were administered albumin-bound paclitaxel injection (Kealil)/paclitaxel injection (Taxol)/Fuquintinib capsule (Aiutec, Fruquintinib).

CVL218 was administered at two dose levels, ranging from low to high (500 mg, 700 mg), twice daily (BID), during the exploration of cohorts in Phase Ib. After determining the recommended dose of CVL218 in all cohorts of the three-drug combination, this dose level was maintained during Phase II. When CVL218 and the combination were administered on the same day, CVL218 was given first.

Being tested
CVL218
Keywords
Triple negative breast cancer, stomach cancer, Intestinal cancer
Medical subject headings
Triple Negative Breast Neoplasms, Stomach Neoplasms, Intestinal Neoplasms

What participants receive

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

  • CVL218Drug

    Also called Toripalimab、Paclitaxel For Injection (Albumin Bound)、Sintilimab、Paclitaxel Injection、Fruquintinib

    Arm1: Triple negative breast cancer CVL218 is administered orally Triplelizumab injection was administered intravenously (IV) 240mg on D1 Paclitaxel injection (Kealil) 125mg /m2, D1, D8 administration Every 21 days for a drug cycle; Arm2: Gastric cancer CVL218 is administered orally Sindilizumab injection was given intravenously (IV) 200mg on D1 Paclitaxel injection (Taxol) 175mg /m2, D1 administration Every 21 days for a drug cycle; Arm3: Intestinal cancer CVL218 is administered orally Sindilizumab injection was given intravenously (IV) 200mg on D1 Fuquinitinib capsule 5mg QD orally, D1-14 administration Every 21 days is a medication cycle.

Study groups in NCT06078670
Study groupRoleWhat they receive
Triple Negative Breast CancerExperimentalCVL218+Toripalimab+Paclitaxel For Injection (Albumin Bound)
Receives: Drug: CVL218
Stomach cancerExperimentalCVL218+Sintilimab+Paclitaxel Injection
Receives: Drug: CVL218
Intestinal cancerExperimentalCVL218+Sintilimab+Fruquintinib
Receives: Drug: CVL218

What is being measured

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

  1. Incidence of dose-limiting toxicity (DLT) during the observation period of DLT

    The duration of DLT evaluation in Phase Ib is within the first cycle after dosing (within 21 days). Starting from the 500mg BID CVL218 dose group, each dose group was enrolled on the basis of 3 cases. If DLT was present in 2/3 or more of the group, one dose level should be lowered. If 1/3 of the subjects developed DLT, 3 more subjects were enrolled with the same dose. If 2/6 or more subjects develop DLT, the dose level should be lowered by one dose. After each dose group completes the DLT assessment, it is decided whether to move to the next dose group. The recommended dose (RP2D) will be determined based on the combined data of safety and tolerability, PK, pharmacodynamics, and initial anti-tumor efficacy of the drug obtained during the dose escalation phase. If dose-limiting toxicity (DLT) occurs in 0/3 subjects in a group, or in less than 2/6 subjects, the CVL218 dose can be used as the recommended dose.

    Measured: Incidence of dose-limiting toxicity (DLT) during the observation period of DLT，No more than six months；The interruption and reduction of drug dose in the cohorts of the combination regimen were studied，No more than three years

Secondary outcomes (1)

  1. Duration of response (DoR), progression-free survival (PFS), disease control rate (DCR)as assessed by the RECIST v1.1

    Duration of response (DoR), progression-free survival (PFS), disease control rate (DCR)as assessed by the RECIST v1.1

    Measured: Imaging evaluation was performed every 6 weeks (±7 days) for six months prior to treatment. After six months, they were evaluated every 12 weeks (±7 days). Tumor evaluation can be performed more frequently by the investigator according to clinical needs.

Timeline

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

  1. First posted12 Oct 2023
  2. Study start10 Oct 2023 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (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
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078670
Sponsor's protocol ID
CVL218-1003
Status last verified
Oct 2023
First submitted
18 Sep 2023
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CVL218 in people with Advanced Solid Tumor, run by Fujian Cancer Hospital.

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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (DLT) during the observation period of DLT (time frame: Incidence of dose-limiting toxicity (DLT) during the observation period of DLT，No more than six months；The interruption and reduction of drug dose in the cohorts of the combination regimen were studied，No more than three years). 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 NCT06078670.

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 12 Oct 2023.

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