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Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)

ConditionsCarcinomaSquamous Cell Carcinoma of Head and NeckUrothelial CarcinomaProstate CancerSmall-cell Lung CancerNon-small Cell Lung CancerCervical CancerOther Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvopoint Biosciences Inc.

About this trial

In this study, participants with different types of advanced solid tumors who failed standard treatments will be treated with XNW5004 in combination with KEYTRUDA® (pembrolizumab) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign informed consent form prior to the commencement of any research activity/procedure.

Age ≥ 18.

Cohort 3 (mCRPC cohort) is male-only, and no gender restrictions for other cohorts.

Cohort: 1 Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including nasopharyngeal carcinoma),has progressed after treatment with a standard regimen containing PD-1/PD-L1 inhibitors.

Disqualifiers

Cohort 1 (head and neck squamous cell carcinoma cohort)

Neuroendocrine carcinoma and small cell carcinoma.

Salivary adenocarcinoma or other non squamous cell carcinoma (such as adenocarcinoma, sarcoma or mixed carcinoma) confirmed by histology or cytology, and metastatic squamous cell carcinoma with unknown primary origin. This exclusion criterion is not applicable to nasopharyngeal cancer.

Cohort 3 (mCRPC)

Trial design

Design model

Parallel

Treatments tested in this trial

  • XNW5004

    Drug

    XNW5004 an EZH2 inhibitor, BID, administered in continuous

  • KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection

    Drug

    KEYTRUDA® (pembrolizumab) a programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.

Treatment groups

204 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose escalation and Safety of XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase Ib)Experimental treatment 2 interventions
Group B: HNSCC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 1)Experimental treatment 2 interventions
Group C: Urothelial carcinoma：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 2)Experimental treatment 2 interventions
Group D: mCRPC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 3)Experimental treatment 2 interventions
Group E: Small cell lung cancer：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 4)Experimental treatment 2 interventions
Group F: non-small cell lung cancer:XNW5004 in combination with KEYTRUDA®(pembrolizumab)(PhaseII-cohort5)Experimental treatment 2 interventions
Group G: ：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 6)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose (RP2D) of XNW5004 in Combination With KEYTRUDA® (pembrolizumab) (Phase 1b Only)

Recommended Phase 2 dose (RP2D) of XNW5004 as administered orally twice daily (BID), continuously in 21-day cycles, in combination with KEYTRUDA® (pembrolizumab) in subjects with advanced solid tumors by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data

Time frame
The first 21-day cycle of therapy
2

Objective Response Rate (ORR) (Phase 2)

ORR is defined as the proportion of subjects who have a confirmed complete response (CR) or a partial response (PR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

Time frame
Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease

Secondary outcomes

1

ORR(Phase 1b)

ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1.

Time frame
Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
2

Duration of response (DOR)(Phase 1b and Phase 2)

DOR is defined defined as the length of time from the date of first confirmed CR or PR per RECIST 1.1(whichever status is recorded first) to the date of first evaluation of progressive disease, or death due to any reasons.

Time frame
Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
3

Progression free survival (PFS) (Phase 1b and Phase 2)

PFS is defined as the the length of time from the date of first administration of the study drug until the date of disease progression or death.

Time frame
Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
4

Percentage of Participants With Adverse Events（AE） (Phase 2）

An AE is any untoward medical occurrence in a clinical investigation subject administered a study drug and an AE can therefore be any symptom, disease or an abnormal laboratory finding, whether or not related to the investigational product. Severity of AEs is assessed according to Common Terminology Criteria for Adverse Events Version (CTCAE 5.0).

Time frame
Up to 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evopoint Biosciences Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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