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Solid TumorPhase 1NCT04601402

GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

A Phase 1 study testing GEN-001 and Avelumab in people with Solid Tumor and Non Small Cell Lung Cancer, run by Genome & Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEN-001 and Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesUnited States
Study dates
26 Oct 2020to 11 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ functions as defined in the protocol
  • Negative childbearing potential
  • Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities
  • Patients with diseases for which no curative therapies are available, and who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)
  • Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
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  • Patients who have completely recovered from any clinically significant AEs that occurred during prior immunotherapy
  • Estimated life expectancy of at least 3 months
  • Objective evidence of disease progression at baseline (Dose Escalation)
  • Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic NSCLC, SCCHN, and UC (Dose Expansion)
  • Measurable disease as per RECIST v1.1 defined as at least 1 lesion (Dose Expansion)

Who cannot join

  • Have experienced primary resistance to anti-PD-(L)1 based therapy
  • Has experienced a toxicity that led to permanent discontinuation of prior anti-PD-(L)1 based therapy or other immunotherapies
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Current use of immunosuppressive medication at time of study entry
  • Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within the previous 4 weeks of starting study treatment
  • Has received a live vaccine within 4 weeks of starting of study treatment
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  • Known history of, or any evidence of active, non-infectious pneumonitis
  • Prior solid organ or allogeneic stem cell transplantation
  • Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks of starting study treatment
  • Has received proton pump inhibitors (PPIs) within 2 weeks prior to dosing study treatments
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has clinically significant (i.e., active) cardiovascular disease
  • Has known history of uncontrolled intercurrent illness
  • Has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

Being tested
GEN-001, Avelumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEN-001Drug

    The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10^11 colony-forming units (CFU)

  • AvelumabDrug

    Also called Bavencio

    800 mg given by intravenous (IV) infusion once every 2 weeks

Study groups in NCT04601402
Study groupRoleWhat they receive
GEN-001 with avelumabExperimentalDose Escalation Cohort includes patients with advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels. Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)will be enrolled.
Receives: Drug: GEN-001; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation: Incidence of Adverse Events

    Assessed as per CTCAE v5.0

    Measured: 1 years

  2. Dose Escalation: Incidence of Laboratory abnormalities

    Assessed as per CTCAE v5.0

    Measured: 1 years

  3. Dose Escalation: Incidence of dose-limiting toxicity (DLT)

    To evaluate the safety and tolerability of GEN-001 in combination with avelumab

    Measured: 1 Cycle (one cycle = 28 days)

  4. Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab.

    Confirmed OR per RECIST v1.1 by the Investigator

    Measured: 2 years

Secondary outcomes (7)

  1. Objective Response (OR)

    Assessed according to RECIST v1.1

    Measured: 1 years

  2. Duration of response (DoR)

    Assessed according to RECIST v1.1

    Measured: up to 2 years

  3. Progression-free survival (PFS)

    Assessed according to RECIST v1.1

    Measured: up to 2 years

  4. Overall Survival (OS)

    Measured: up to 2 years

  5. Incidence of Adverse Events

    Assessed as per CTCAE v5.0

    Measured: up to 2 years

  6. Incidence of Laboratory Abnormalities

    Assessed as per CTCAE v5.0

    Measured: up to 2 years

  7. irOR (Immune-related Objective Response)

    Assessed according to irRECIST

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start26 Oct 2020
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Dose Escalation: Seqeuntial Group Assignment, Dose Expansion: Parallel Group Assignment
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601402
Sponsor's protocol ID
[GNC] GEN001-101
Status last verified
Jun 2023
First submitted
13 Oct 2020
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEN-001 and Avelumab in people with Solid Tumor and Non Small Cell Lung Cancer, run by Genome & Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation: Incidence of Adverse Events (time frame: 1 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04601402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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