CompletedNCT03674567Updated Sep 3, 2026Results posted

Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab

A Phase 1/2 interventional study of FLX475 (tivumecirnon) and pembrolizumab (KEYTRUDA®) in Advanced Cancer, sponsored by RAPT Therapeutics, Inc.. Completed at 35 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by RAPT Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 323
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Conditions studied

Advanced Cancer

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Keywords

Non-small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Breast Cancer
Urothelial Carcinoma
Nasopharyngeal Carcinoma
Cervical Cancer
Lymphoma

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 323 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

RAPT Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies
- Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma
- Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
Tumor available for biopsy

Exclusion criteria

Exclusion Criteria:

History of allergy or severe hypersensitivity to biologic agents
History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
Active graft-versus-host disease

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 323 participants (actual)

Study arms

Experimental
Part 1a: Monotherapy Dose Escalation
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
Drug: FLX475 (tivumecirnon)
Experimental
Part 1b: Combination Dose Escalation
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
Drug: FLX475 (tivumecirnon) · Drug: pembrolizumab (KEYTRUDA®)
Experimental
Part 2a: Monotherapy Expansion Cohorts
Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.
Drug: FLX475 (tivumecirnon)
Experimental
Part 2b: Combination Expansion Cohorts
Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.
Drug: FLX475 (tivumecirnon) · Drug: pembrolizumab (KEYTRUDA®)

Interventions

DrugFLX475 (tivumecirnon)
tablet
Drugpembrolizumab (KEYTRUDA®)
IV infusion

What researchers measure

Primary outcomes

Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
treatment-emergent adverse events
Time frame: Approximately 18 weeks
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Summary of Best Overall Response
Time frame: Through study completion (approximately 2 years)

Results

Posted Sep 3, 2026

Participant flow

Participant flow — Overall Study
Milestone	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
Started	3	3	7	6	3	4	11	12	20	13	11	21	30	32	24	15	46	40	12	10
Completed	0	0	0	1	1	1	0	0	0	0	0	0	3	3	0	0	7	4	0	0
Not completed	3	3	7	5	2	3	11	12	20	13	11	21	27	29	24	15	39	36	12	10

Outcome measures

PrimarySafety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose

treatment-emergent adverse events

Time frame:: Approximately 18 weeks
Reported as:: Number · participants

Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
participants	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
Related TEAE	2	3	6	6	3	2	8	8	14	10	9	12	25	23	18	10	36	31	7	8
Grade ≥ 3 TEAE	0	1	5	4	2	3	8	4	11	5	7	4	19	19	14	4	20	19	8	5
Related Grade ≥ 3 TEAE	0	1	1	2	0	0	1	3	1	1	0	2	9	6	5	3	11	6	5	1

PrimaryOverall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab

Summary of Best Overall Response

Time frame:: Through study completion (approximately 2 years)
Reported as:: Count of participants · Participants

Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Participants	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
Complete response by RECIST 1.1/iRECIST or Lugano	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	1	0	0	0
Partial response by RECIST 1.1/iRECIST or Lugano	0	0	0	0	1	0	1	0	2	0	0	0	2	5	1	0	6	11	1	1
Stable disease by RECIST 1.1/iRECIST or Lugano	1	2	2	2	1	2	3	4	2	3	3	4	7	11	9	2	13	14	2	3
PD by RECIST 1.1/iRECIST or Lugano	2	1	3	3	1	1	5	8	13	7	6	14	15	11	11	12	22	10	7	4
Inevaluable by RECIST 1.1/iRECIST or Lugano	0	0	0	1	0	1	0	0	0	1	0	0	2	1	0	0	0	1	0	0
Subjects have missing tumor response assessment, therefore were not counted in the summary	0	0	1	0	0	0	2	0	2	2	1	2	3	4	2	1	3	3	2	2

Adverse events

Collected over approximately 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	0/3 (0%)	0/3 (0%)	2/3 (66.7%)
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	0/3 (0%)	0/3 (0%)	3/3 (100%)
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	0/7 (0%)	0/7 (0%)	6/7 (85.7%)
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	0/6 (0%)	0/6 (0%)	6/6 (100%)
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	0/3 (0%)	0/3 (0%)	3/3 (100%)
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	0/4 (0%)	0/4 (0%)	2/4 (50%)
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	2/11 (18.2%)	1/11 (9.1%)	8/11 (72.7%)
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	0/12 (0%)	0/12 (0%)	8/12 (66.7%)
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	0/20 (0%)	0/20 (0%)	14/20 (70%)
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	1/13 (7.7%)	1/13 (7.7%)	10/13 (76.9%)
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	0/11 (0%)	0/11 (0%)	9/11 (81.8%)
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	1/21 (4.8%)	0/21 (0%)	12/21 (57.1%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	0/30 (0%)	3/30 (10%)	25/30 (83.3%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	4/32 (12.5%)	2/32 (6.3%)	23/32 (71.9%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	2/24 (8.3%)	3/24 (12.5%)	18/24 (75%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	0/15 (0%)	1/15 (6.7%)	10/15 (66.7%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	3/46 (6.5%)	3/46 (6.5%)	36/46 (78.3%)
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	2/40 (5%)	2/40 (5%)	31/40 (77.5%)
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	0/12 (0%)	2/12 (16.7%)	7/12 (58.3%)
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)	2/10 (20%)	1/10 (10%)	8/10 (80%)

Most frequent serious events

Showing 10 of 20

Most frequent serious events
Event	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
PneumonitisRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/7	0/6	0/3	0/4	1/11	—	—	0/13	—	—	3/30	0/32	2/24	0/15	1/46	1/40	0/12	0/10
Pneumothorax spontaneousRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	0/32	0/24	0/15	0/46	0/40	0/12	1/10
DiarrhoeaGastrointestinal disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	0/32	0/24	0/15	0/46	0/40	1/12	0/10
PyrexiaGeneral disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	0/32	0/24	0/15	0/46	0/40	1/12	0/10
Electrocardiogram QT prolongedInvestigations	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	1/13	—	—	0/30	0/32	0/24	0/15	0/46	0/40	0/12	0/10
Meningitis asepticInfections and infestations	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	0/32	0/24	1/15	0/46	0/40	0/12	0/10
SclerodermaMusculoskeletal and connective tissue disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	0/32	1/24	0/15	0/46	0/40	0/12	0/10
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	1/30	0/32	0/24	0/15	0/46	0/40	0/12	0/10
PneumoniaInfections and infestations	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	1/30	0/32	0/24	0/15	0/46	0/40	0/12	0/10
HyponatraemiaMetabolism and nutrition disorders	0/3	0/3	0/7	0/6	0/3	0/4	0/11	—	—	0/13	—	—	0/30	1/32	0/24	0/15	1/46	0/40	0/12	0/10

Most frequent other events

Showing 10 of 91

Most frequent other events
Event	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
ChillsGeneral disorders	0/3	2/3	0/7	1/6	0/3	0/4	0/11	0/12	0/20	0/13	0/11	0/21	0/30	0/32	0/24	1/15	0/46	0/40	1/12	0/10
HeadacheNervous system disorders	0/3	2/3	0/7	0/6	1/3	0/4	1/11	0/12	0/20	0/13	1/11	0/21	1/30	0/32	1/24	2/15	0/46	2/40	0/12	0/10
AnaemiaBlood and lymphatic system disorders	0/3	0/3	1/7	0/6	2/3	0/4	0/11	0/12	0/20	0/13	0/11	0/21	2/30	3/32	0/24	0/15	2/46	0/40	0/12	2/10
Electrocardiogram QT prolongedInvestigations	0/3	0/3	4/7	1/6	1/3	0/4	4/11	4/12	7/20	7/13	4/11	8/21	10/30	14/32	10/24	5/15	14/46	20/40	2/12	5/10
RashSkin and subcutaneous tissue disorders	0/3	0/3	0/7	1/6	0/3	2/4	1/11	2/12	5/20	1/13	1/11	2/21	3/30	2/32	2/24	0/15	7/46	12/40	0/12	1/10
FatigueGeneral disorders	1/3	1/3	1/7	0/6	0/3	1/4	3/11	1/12	2/20	0/13	0/11	1/21	5/30	5/32	1/24	2/15	6/46	1/40	5/12	0/10
PyrexiaGeneral disorders	0/3	1/3	1/7	0/6	0/3	0/4	2/11	0/12	0/20	0/13	0/11	0/21	1/30	0/32	0/24	1/15	1/46	0/40	2/12	1/10
AstheniaGeneral disorders	0/3	1/3	0/7	0/6	0/3	0/4	1/11	0/12	0/20	0/13	0/11	0/21	0/30	0/32	0/24	0/15	0/46	0/40	0/12	0/10
Decreased appetiteGeneral disorders	0/3	1/3	1/7	0/6	0/3	0/4	1/11	0/12	0/20	1/13	0/11	0/21	2/30	2/32	1/24	1/15	2/46	3/40	4/12	0/10
HyperhidrosisGeneral disorders	1/3	0/3	0/7	0/6	0/3	0/4	0/11	0/12	0/20	0/13	0/11	0/21	0/30	0/32	0/24	0/15	0/46	0/40	0/12	0/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)	Total
<=18 years	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	2	1	4	5	1	4	6	9	13	9	8	14	23	21	9	15	38	17	10	9	218
>=65 years	1	2	3	1	2	0	5	3	7	4	3	7	7	11	15	0	8	23	2	1	105

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)	Total
Female	1	0	5	5	2	2	6	3	5	3	11	6	1	2	8	15	8	9	1	1	94
Male	2	3	2	1	1	2	5	9	15	10	0	15	29	30	16	0	38	31	11	9	229

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)	Total
Hispanic or Latino	0	0	0	0	0	1	2	0	1	1	1	1	0	1	0	1	0	0	0	0	9
Not Hispanic or Latino	3	3	7	6	3	3	8	11	19	12	10	20	30	30	24	14	46	40	12	10	311
Unknown or Not Reported	0	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg	Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg	Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab	Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)	Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)	Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)	Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	1	4	0	0	1	11	15	9	9	18	26	8	17	6	42	33	12	9	221
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1
Black or African American	0	0	0	1	0	2	1	0	1	1	0	0	0	0	0	1	1	0	0	0	8
White	3	3	5	1	3	2	9	1	3	3	2	3	4	20	7	8	3	7	0	1	88
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	2
Unknown or Not Reported	0	0	1	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	3

Study locations

35 sites

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234, United States
City of Hope
Duarte, California 91010, United States
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California 90024, United States
Yale Cancer Center
New Haven, Connecticut 06510, United States
Georgetown - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia 20007, United States
Comprehensive Hematology and Oncology, LLC
St. Petersburg, Florida 33709, United States
Moffitt Cancer Center
Tampa, Florida 33612, United States
Emory Winship Cancer Institute
Atlanta, Georgia 30322, United States
University of Chicago
Chicago, Illinois 60637, United States
University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky 40202, United States
Johns Hopkins University
Baltimore, Maryland 21231, United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
Quantum Santa Fe
Santa Fe, New Mexico 87505, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York 10032, United States
Carolina BioOncology Institute
Huntersville, North Carolina 28078, United States
Mary Crowley Cancer Research Center
Dallas, Texas 75230, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030, United States
University of Washington
Seattle, Washington 98195, United States
Austin Hospital
Heidelberg, Victoria 3084, Australia
Linear Clinical Research Limited
Nedlands, Western Australia 6009, Australia
Queen Mary Hospital - Lymphoma
High West, Hong Kong
Queen Mary Hospital
High West, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Seoul National University
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Chungbuk National University Hospital
Taebuk, 28644, South Korea
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Meidcal Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
King Chulaongkorn Memorial Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand

References and documents

Study documents

Study protocol · Sep 1, 2022
Statistical analysis plan · Jun 9, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03674567
Lead sponsor: RAPT Therapeutics, Inc.
Collaborators: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Sep 17, 2018
Start date: Sep 25, 2018
Primary completion: Dec 31, 2024
Completion: Dec 31, 2024
Results posted: Sep 3, 2026
Last update: Sep 3, 2026

Study contacts

William Ho, MD, PhD

study director · RAPT Therapeutics, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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