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RC88

Phase 1

Solid Tumor | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04175847A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid TumorsPHASE1 COMPLETED 198 — — Apr 14, 2020Dec 31, 2025Jan 7, 20264 China
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Study Endpoints
Primary Endpoints
Phase 1 Adverse events
From the day of ICF sign to 28 days after the day of the last treatment

Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03

Phase 1 Maximum Tolerated dose of RC88
21 days after first treatment.

The dose level in which \>= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.

Phase2
24 weeks

ORR is evaluated by IRC

Secondary Endpoints
Phase 1 Objective Response Rate (ORR)
24 months
Phase 1 Progression Free Survival (PFS)
24 months
Phase 1 and Phase2 Pharmacokinetics (PK) parameter for total antibody (TAb): Maximum concentration (Cmax)
Phase 1:Cycle 1 and Cycle 3 (each cycle is 21 days): pre-dose, 0.5 hour (hr), 1 hr, 1.5 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 120 hrs, 168 hrs, 240 hrs (and 336 hrs) after start of infusion. Cycle 2: pre-dose.Phase2 （Whole test cycle）
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RC88EXPERIMENTAL -
Interventions
NameTypeDescription
RC88DRUGPhase I:Participants will be allocated to one of the following dose groups: 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC88-ADC followed by 21 days of dose limited toxicity (DLT) observation period. Phase IIa indication exploration
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Age requirements ：phase I 18-70 (including 18 and 70) ,IIa ≥18 years old. * Predicted survival ≥ 12 weeks. * Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progressi...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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