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NCT07102004
A Phase I/II Study of MHB088C for Patients With Advanced Malignant Solid Tumors
Phase 1/Phase 2 trial testing MHB088C for Injection in Advanced/Metastatic Solid Tumors in 515 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 515 |
| Start date | 20 June 2023 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- MHB088C for Injection — full drug profile →
Conditions studied
- Advanced/Metastatic Solid Tumors — all drugs for Advanced/Metastatic Solid Tumors →
Sponsor
Qilu Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Advanced/Metastatic Solid Tumors. 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.
-
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Time frame: After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) -
Dose limited toxicity (DLT) (Phase Ia)
Time frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks)
The DLTs of MHB088C will be determined. -
Maximum tolerated dose (MTD) (Phase Ia)
Time frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks).
The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle. -
Recommended phase II dose (RP2D) (Phase Ib)
Time frame: Through phase Ib completion, an average of 1 year.
RP2D will be selected upon safety, PK and efficacy data. -
Objective response rate (ORR) (phase II)
Time frame: Approximately 48 months.
The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1
Sponsor's own description
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07102004
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MHB088C for Injection
Trials testing the same drug.
- NCT05652855 — Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Advanced/Metastatic Solid Tumors
Currently open trials in the same condition.
- NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07415863 — Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT05718895 — A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors · Phase 1 · recruiting
- NCT05607498 — First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma · Phase 1 · recruiting
Other Qilu Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07511647 — A Phase 3 Clinical Study of QL2106 Injection · Phase 3 · not yet recruiting
- NCT07467629 — QLS5212 for Participants With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07455006 — Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Phase 3 · not yet recruiting
- NCT07463573 — QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
- NCT07444086 — QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia · Phase 3 · not yet 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 NCT07102004 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Qilu Pharmaceutical Co., Ltd.
- Last refreshed: 28 July 2025
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/NCT07102004.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing