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BRIEF TITLE: A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies

A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies


  • Org Study ID: AB928CSP0005
  • Secondary ID:
  • NCT ID: NCT03629756
  • NCT Alias:
  • Sponsor: Arcus Biosciences, Inc. - Industry
  • Source: Arcus Biosciences, Inc.

Brief Summary

This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of AB928 in combination with AB122 (an anti-PD-1 antibody) in participants with advanced malignancies.

Detailed Description


In the dose-escalation phase, escalating doses of AB928 in combination with AB122 will be
assessed in participants with advanced malignancies. Eligible participants will receive oral
administration of AB928 as well as IV infusion of AB122. The recommended dose for expansion
(RDE) of AB928 will be determined upon completion of the dose-escalation phase.

In the dose-expansion phase, AB928 at RDE in combination with AB122 may be assessed in
participants with advanced clear-cell renal cell carcinoma (RCC) or metastatic
castrate-resistant adenocarcinoma of the prostate (mCRPC).

Overall duration of treatment will depend on how well the treatment is tolerated. Treatment
may continue until unacceptable toxicity or progressive disease or other reasons specified in
the protocol.

Overal Status Start Date Phase Study Type
Recruiting July 24, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Percentage of participants with Adverse Events

Primary Outcome 1 - Time Frame: From first dose date to 90 days after the last dose (approximately 1 year)

Primary Outcome 2 - Measure: Percentage of participants who experience a Dose Limiting Toxicity

Primary Outcome 2 - Time Frame: From first study treatment administration through Day 28

Condition:

  • Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Breast Cancer
  • Colorectal Cancer
  • Melanoma
  • Bladder Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Merkel Cell Carcinoma
  • GastroEsophageal Cancer
  • Renal Cell Carcinoma
  • Castration-resistant Prostate Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Male or female participants ≥ 18 years

2. Must have at least 1 measurable lesion per RECIST v1.1.

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

4. Must have received standard of care, including potentially curative available
therapies or interventions.

5. Confirm that an archival tissue sample is available and ≤ 6 months old; if not, a new
biopsy of a tumor lesion must be obtained. Biopsy must not put participant at undue
risk and procedure must not be more invasive than a core biopsy.

6. Adequate organ and marrow function

Dose escalation only:

7. Pathologically confirmed non-small cell lung cancer, squamous cell carcinoma of the
head and neck, renal cell carcinoma, breast cancer, colorectal cancer, melanoma,
bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, or
gastroesophageal cancer that is metastatic, advanced or recurrent with progression for
which no alternative or curative therapy exists or standard therapy is not considered
appropriate by the participant and treating physician (reason must be documented in
medical records).

Dose expansion only:

8. Patients with advanced clear-cell RCC or mCRPC.

9. Clear-cell RCC patients may have received up to 2 prior lines of therapy, one of which
must have included an anti-PD-(L)1 based therapy and must not have progressed within
16 weeks during an anti-PD-(L)1 therapy.

10. mCRPC patients must have progressed during or following treatment with an androgen
synthesis inhibitor, and have also had one prior line of a taxane-containing regimen
or the physician and participant consider the taxane-containing regimen to be
inappropriate. mCRPC patients must be naive to any immunotherapy (including but not
limited to anti-PD-(L)1 or anti-CTLA-4 antogonists, sipuleucel-T, etc.).

Exclusion Criteria:

1. Use of any live vaccines against infectious diseases (eg, influenza, varicella) within
4 weeks (28 days) of initiation of investigational product.

2. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will
make the administration of investigational product hazardous (eg, interstitial lung
disease, active infections requiring antibiotics, recent hospitalization with
unresolved symptoms) or obscure the interpretation of toxicity determination or AEs,
or concurrent medical condition requiring the use of immunosuppressive medications or
immunosuppressive doses of systemic or absorbable topical corticosteroids.

3. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

4. Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the pre-screening or screening visit
through 90 days after the last dose of AB928 in combination with AB122.

5. Any active or documented history of autoimmune disease, or history of a syndrome that
required systemic steroids or immunosuppressive medications, except for vitiligo or
resolved childhood asthma/atopy. Participants with asthma who require intermittent use
of bronchodilators (such as albuterol) will not be excluded from this study.

6. Prior malignancy active within the previous year except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer or carcinoma in situ of the cervix, breast, or prostate
cancer.

7. Dose escalation: Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other
immune checkpoint inhibitor or agonist as a monotherapy or in combination;

8. Use of other investigational drugs (drugs not marketed for any indication) within 28
days or at least 5 half-lives (whichever is longer) before investigational product
administration.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Medical Director

Role: Study Director

Affiliation: Arcus Biosciences, Inc.

Overall Contact

Name: Medical Director

Phone: 510-694-6200

Email: ClinicalTrialInquiry@arcusbio.com

Locations

Facility Status Contact
Scottsdale, AZ
Scottsdale, Arizona 85258
United States
Recruiting Principal Investigator

Los Angeles, CA
Los Angeles, California 90025
United States
Recruiting Principal Investigator

Los Angeles
Los Angeles, California 90095
United States
Recruiting Principal Investigator

Denver, CO
Denver, Colorado 80218
United States
Recruiting Principal Investigator

Ann Arbor
Ann Arbor, Michigan 48109
United States
Recruiting Principal Investigator

Royal Oak
Royal Oak, Michigan 48073
United States
Recruiting Principal Investigator

Huntersville, NC
Huntersville, North Carolina 28078
United States
Recruiting Principal Investigator

Greenville, South Carolina
Greenville, South Carolina 29605
United States
Recruiting Principal Investigator

Fort Worth
Fort Worth, Texas 76104
United States
Recruiting Principal Investigator

San Antonio, TX
San Antonio, Texas 78240
United States
Recruiting Principal Investigator

Tyler, TX
Tyler, Texas 75702
United States
Recruiting Principal Investigator

Spokane, WA
Spokane, Washington 99208
United States
Recruiting Principal Investigator

Kogarah, Australia
Kogarah, New South Wales 2217
Australia
Recruiting Principal Investigator

Greenslopes, Australia
Greenslopes, Queensland 4120
Australia
Completed
Malvern, Australia
Malvern, 3144
Australia
Recruiting Principal Investigator