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VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma

ConditionsHead and Neck CarcinomaAdenoid Cystic CarcinomaLung CancerNon-Small Cell Lung CancerPancreatic CancerMesotheliomaEsophageal CancerAny Solid Tumors Progressed After a Prior ImmunotherapyHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCCSalivary Gland CarcinomasHead and Neck Cancers - Salivary GlandHead and Neck Cancers - NasopharyngealHead and Neck Cancers - ThroatSmall Cell Lung Cancer ( SCLC )Lung Cancer (Locally Advanced or Metastatic)Head and Neck Cancers - TonsilsHead and Neck Cancers HypopharynxHead and Neck Cancers LarynxHead and Neck Cancers LipHead and Neck Cancers NasopharynxHead and Neck Cancers Oral CavityHead and Neck CancersHead and Neck Cancers OropharynxHead and Neck Cancers Trachea
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVM Oncology, LLC

About this trial

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Head and Neck Cancers ("HNC") (of any types),

Esophageal cancer,

Lung cancers (of any types),

Mesothelioma,

Disqualifiers

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).

Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.

Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.

Unresolved toxicity from previous anticancer therapy > CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VMD-928 100 mg Tablet

    Drug

    Taken orally once daily for 21 days per 21-day cycle

  • VMD-928 Tablet and Pembrolizumab (200 mg)

    Drug

    VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: VMD-928 monotherapyExperimental treatment 1 intervention
Group B: Combination TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number and severity of treatment-emergent Adverse Events (Phase 1)

TEAE

Time frame
First cycle (21 days per cycle)
2

To determine the recommended Phase 2 dose for VMD-928 (Phase 1)

RP2D of monotherapy

Time frame
First cycle (21 days per cycle)
3

To determine the RP2D of VMD-928 in combination with pembrolizumab (Phase 1)

RP2D of combination therapy

Time frame
First cycle (21 days per cycle)
4

Antitumor activity of VMD-928 in subjects with TrkA-driven tumors (Phase 2)

Antitumor efficacy signal for monotherapy

Time frame
Up to 18 months

Secondary outcomes

1

Area under the plasma concentration versus time curve (AUC) of VMD-928.

AUC

Time frame
On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
2

Peak plasma concentration (Cmax) of VMD-928.

Cmax

Time frame
On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
3

Incidence of Dose Limiting Toxicities.

\# of DLTs

Time frame
During the Cycle 1 (each cycle is 21 days)
4

Correlation between clinical antitumor and TrkA protein expression.

Relationship of TrkA vs. efficacy

Time frame
Up to the end of the Cycle 2 (each cycle is 21 days)

Other outcomes

Sponsors and contacts

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

VM Oncology, LLC

Lead sponsor

Source ClinicalTrials.gov
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