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NCT06078670
Phase Ib/II Clinical Study of PARP Inhibitor CVL218 in Combination With Therapy in Patients With Advanced Solid Tumors
Phase 1/Phase 2 trial testing CVL218 in Advanced Solid Tumor in 96 participants. Not yet recruiting.
1 June 2026
Quick facts
| Lead sponsor | Fujian Cancer Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 10 October 2023 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2026 |
Drugs / interventions tested
- CVL218 — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Fujian Cancer Hospital
Who can join
Adults 18 to 75, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
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 devel
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Genome instability and crosstalk with the immune response.
Chabanon RM, Danlos FX, Ouali K, Postel-Vinay S. · · 2025 · cited 4× · PMID 41188872 · DOI 10.1186/s13073-025-01509-6 -
Triple-Negative Breast Cancer Systemic Treatment: Disruptive Early-Stage Developments for Overcoming Stagnation in the Advanced Pipeline.
Alonso-Ron C, Vethencourt A, González-Suárez E, Oruezabal RI. · · 2025 · cited 4× · PMID 40002228 · DOI 10.3390/cancers17040633 -
Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.
Xu RC, Zhang YW, Liu CC, Xu YY, et al · · 2025 · cited 3× · PMID 40443538 · DOI 10.1016/j.lanwpc.2024.101180
Verify or expand the search:
- PubMed search for NCT06078670
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
Other Fujian Cancer Hospital trials
Trials by the same sponsor.
- NCT07470840 — SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma · Phase 2 · not yet recruiting
- NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
- NCT07492654 — Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream · Phase 4 · not yet recruiting
- NCT07399158 — CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Respons · not yet recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06078670 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fujian Cancer Hospital
- Last refreshed: 9 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06078670.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing