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FOG-001 in Locally Advanced or Metastatic Solid Tumors

ConditionsCancerColorectal CancerSolid TumorLocally Advanced Solid TumorMetastatic CancerWNT PathwayHCCDesmoidMicrosatellite Stable Colorectal CancerMetastatic Castration-resistant Prostate CancerFamilial Adenomatous Polyposis (FAP)Endometrial CarcinomaProstate CancerMicrosatellite Instability-High Colorectal CancerAdamantinomatous Craniopharyngioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorParabilis Medicines, Inc.

About this trial

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Adequate organ and marrow function.

Diagnosis of treatment-refractory advanced/metastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).

Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.

Disqualifiers

Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.

Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.

Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.

Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)

Trial design

Design model

Sequential

Treatments tested in this trial

  • FOG-001

    Drug

    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days

  • mFOLFOX-6

    Drug

    mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001

  • Nivolumab

    Drug

    Nivolumab will be administered per the prescribing information in combination with FOG-001

  • Trifluridine/tipiracil

    Drug

    Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001

  • Bevacizumab

    Drug

    Bevacizumab will be administered per the prescribing information in combination with FOG-001

  • FOG-001

    Drug

    FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

Treatment groups

619 Participants
are divided into 19 treatment groups

19

Treatment groups

See each treatment group below.

Group A: Part 1aExperimental treatment 1 intervention
Group B: Part 1bExperimental treatment 1 intervention
Group C: Part 1cExperimental treatment 1 intervention
Group D: Part 1d-1Experimental treatment 1 intervention
Group E: Part 1d-2Experimental treatment 1 intervention
Group F: Part 1f-1Experimental treatment 3 interventions
Group G: Part 1f-2Experimental treatment 2 interventions
Group H: Part 1f-3Experimental treatment 3 interventions
Group I: Part 1gExperimental treatment 1 intervention
Group J: Part 1hExperimental treatment 1 intervention
Group K: Part 1iExperimental treatment 1 intervention
Group L: Part 2aExperimental treatment 1 intervention
Group M: Part 2bExperimental treatment 1 intervention
Group N: Part 2cExperimental treatment 1 intervention
Group O: Part 2dExperimental treatment 1 intervention
Group P: Part 2eExperimental treatment 1 intervention
Group Q: Part 2f-1Experimental treatment 3 interventions
Group R: Part 2f-2Experimental treatment 2 interventions
Group S: Part 2f-3Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0

Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0

Time frame
Through study completion, an average of 10 months
2

During dose escalation characterize dose-limiting toxicities (DLTs)

Incidence of DLTs

Time frame
1 treatment cycle (28 days)
3

During dose expansion describe the Overall Response Rate using RECIST v1.1

The rate of objective responses (Partial \& Complete) using RECIST v1.1

Time frame
Every 63 days until study completion, approximately 10 months on average
4

During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)

The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1

Time frame
4 months

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) of FOG-001 and associated metabolites

Time frame
During first 2 cycles (56 days)
2

Time to achieve Cmax (Tmax) of FOG-001 and associated metabolites in plasma

Time frame
During first 2 cycles (56 days)
3

Area under the plasma concentration-time curve (AUC) of FOG-001 and associated metabolites

Time frame
During first 2 cycles (56 days)
4

Plasma trough concentration (Ctrough) of FOG-001 and associated metabolites

Time frame
During first 2 cycles (56 days)

Other outcomes

Sponsors and contacts

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

Parabilis Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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