A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
Status: | Recruiting |
---|---|
Conditions: | Skin Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | June 29, 2016 |
End Date: | July 19, 2021 |
Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
Phone: | 1-317-615-4559 |
A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT)
The main purpose of this study is to evaluate the safety and tolerability of anti-programmed
cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced
refractory solid tumors.
cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced
refractory solid tumors.
Inclusion Criteria:
- Histologic or cytologic confirmation of advanced solid tumor.
- For LY3300054 + abemaciclib only: No participants with liver metastases. Participants
must have normal aspartate aminotransferase (AST), alanine aminotransferase (ALT),
total bilirubin, direct bilirubin.
- For LY3300054 + abemaciclib in HR+, HER- breast cancer:
- Express at least 1 of the hormone receptors [HR; estrogen receptor (ER) or
progesterone receptor (PR)] by immunohistochemistry (IHC) to fulfill the
requirement for HR+ disease on the primary tumor or metastatic lesion of the
breast cancer. ER and PR assays are considered positive if there is at least 1%
positive tumor nuclei in their sample as defined in the relevant American Society
of Clinical Oncology (ASCO)/College of American Pathologists (CAP) or local
guidelines.
- To fulfill the requirement of HER2- disease, a breast cancer must not
demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of
HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant
ASCO/CAP or local guidelines.
- Most recent HR and HER2 receptor testing should be used to determine eligibility.
- Have previously received prior treatment with at least 1 but no more than 3
chemotherapy regimens in the metastatic setting.
- Have AST, ALT, GGT, and AP that are ≤2.5x upper limit of normal (ULN) and normal
bilirubin (total and direct) regardless of liver involvement.
- For LY3300054 + merestinib in pancreatic cancer:
- Histologically or cytological confirmed diagnosis of metastatic or locally
advanced, unresectable pancreatic adenocarcinoma (excluding other pancreatic
malignancies for example, acinar cell carcinomas, adenosquamous carcinomas, and
neuroendocrine islet cell neoplasms).
- Have had disease progression, be refractory or intolerant to no more than 2 prior
systemic regimens.
- For LY3300054 + LY3321367 in PD-1/PD-L1-naive, MSI-H/MMR-deficient advanced solid
tumors:
- Have histologically or cytologically confirmed diagnosis of advanced solid tumor
AND shown to be MSI-H or MMR-deficient.
- For LY3300054 + LY3321367 in PD-1/PD-L1- resistant/refractory, MSI-H/MMR-deficient
advanced solid tumors:
- Have histologically or cytologically confirmed diagnosis of advanced solid tumor
AND shown to be MSI-H or MMR-deficient.
- Prior exposure to PD-1/PD-L1 agent regardless of response.
- For Phase 1b LY3300054 monotherapy or combination therapy, no prior treatment with a
PD-1 or PD-L1 agent is allowed.
- Exception: the LY3321367 combination in participants with PD-1/PD-L1-
resistant/refractory, MSI-H, where prior exposure to PD-1/PD-L1 agent required.
- For Phase 1a LY3300054 monotherapy or combination therapy, previous immunotherapy is
acceptable if the following criteria are met:
- Must not have experienced a toxicity that led to permanent discontinuation of
prior immunotherapy.
- Must have completely recovered or recovered to baseline prior to screening from
any prior adverse events (AEs) occurring while receiving prior immunotherapy.
- Must not have experienced a Grade ≥3 immune-related AE or an immune-related
neurologic or ocular AE of any grade while receiving prior immunotherapy.
- Must not have required the use of additional immunosuppressive agents other than
corticosteroids for the management of an AE, not have experienced recurrence of
an AE if re-challenged, and not currently require maintenance doses of >10
milligrams prednisone or equivalent per day.
- Have at least 1 measurable lesion assessable using standard techniques by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have adequate organ function.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
scale.
- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
- Have submitted a tumor tissue sample, as follows:
- For participants entering the Phase 1a dose escalation: have submitted, if
available, the most recent archival tumor tissue sample.
- For those participating ONLY in Phase 1b expansions: Have submitted tumor tissue
sample from a newly obtained core or excisional biopsy for a tumor lesion
(preferred) or a recent biopsy taken with 3 months prior to study enrollment and
following the participants most recent prior systemic treatment and be willing to
undergo a biopsy procedure during the study treatment period for collection of
additional tumor tissue sample.
Exclusion Criteria:
- Have a serious concomitant systemic disorder including human immunodeficiency virus
(HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active
autoimmune disorder or disease requiring high dose of steroids.
- Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection or chronic diarrhea.
- Have evidence of interstitial lung disease that is symptomatic or may interfere with
the detection or management of suspected drug-related pulmonary toxicity or active,
noninfectious pneumonitis.
- Have an active infection requiring systemic therapy.
- Have moderate or severe cardiovascular disease.
- Have symptomatic or uncontrolled brain metastases, spinal cord compression, or
leptomeningeal disease requiring concurrent treatment.
- Have received a live vaccine within 30 days before the first dose of study treatment.
- Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode
within 12 weeks prior to enrollment.
We found this trial at
5
sites
San Antonio, Texas 78229
Principal Investigator: Amita Patnaik
Phone: 210-593-5270
Click here to add this to my saved trials
Brussels,
Principal Investigator: Jean-Pascal Machiels
Phone: 327645106
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Timothy Yap
Phone: 713-745-6754
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Chock Bendell
Phone: 6153297274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
Click here to add this to my saved trials