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CG009301

Phase 1

Leukemia | Small molecule | Oncology |Pulmatrix, Inc.|Last Updated: Jan 16, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07347171A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological MalignanciesPHASE1 RECRUITING 45 — — Apr 17, 2025Dec 30, 2027Jan 16, 20263 China
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Study Endpoints
Primary Endpoints
The RDE(Recommended Dose for Expansion)of CG009301 for injection.
up to 8 months

RDE refer to recommended dose for expansion

Duration of continuous administration and dosing cycle for CG009301 for injection
up to 20 months
Safety profile of CG009301 for injection: Incidence, severity, duration, outcome, and relationship to the study drug for adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), and clinically significant laboratory abnormalitie
up to 20 months
Secondary Endpoints
Cmax
up to 20 months
Tmax
up to 20 months
AUC0-t
up to 20 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.25mg QDEXPERIMENTALCG009301 for Injection
0.5mg QDEXPERIMENTALCG009301 for Injection
1.0mg QDEXPERIMENTALCG009301 for Injection
1.6mg QDEXPERIMENTALCG009301 for Injection
2.5mg QDEXPERIMENTALCG009301 for Injection
3.5mg QDEXPERIMENTALCG009301 for Injection
5.0mg QDEXPERIMENTALCG009301 for Injection
6.5mg QDEXPERIMENTALCG009301 for Injection
8.25mg QDEXPERIMENTALCG009301 for Injection
10.0mg QDEXPERIMENTALCG009301 for Injection
Interventions
NameTypeDescription
CG009301 for InjectionDRUG0.9% Sodium Chloride Injection diluted to 250mL，Cycle 1 and subsequent cycles, IV, infusion duration: 2 hours, once daily (QD) administration for 7 days continuously(28 days constituting one cycle)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Age ≥18 years and \<75 years at the time of signing the informed consent form; no gender restrictions; 2. Patients with relapsed/refractory haematological malignancies who have received a definitive diagnosis by pathology and/or cytology, confirmed histologically, and who hav...

Countries:China
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Competitive Landscape -Leukemia 332 trials
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Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC14PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab, Bendamustine
AbbVie, Inc.ABBV24PHASE3Venetoclax, Acalabrutinib, Obinutuzumab, Fludarabine, Cytarabine
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
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Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
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Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen, revumenib, cobicistat, SNDX-5613
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SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine, CC-486, AG-120, AG-221, BMS-986497
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine - Cytarabine - Gilteritinib, Inotuzumab ozogamicin, ALLR3, SEA-CD70, azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine, Ivosidenib, Ivosidenib + azacitidine, BN104 monotherapy
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib, Imatinib, Lisaftoclax, Acalabrutinib, Fludarabine
Actinium PharmaceuticalsATNM2PHASE3Iomab-B, Conventional Care, 131I-apamistamab, Fludarabine, Cyclophosphamide
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07347171studyFirstPostDate: changed