Clinical trial · Interventional
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer
NCT02632448CI-TRIAL-00089259completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Soft Tissue Sarcoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| LY2880070 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Part A: LY2880070
- description
- Multiple oral doses of LY2880070 during 21-day cycles
- interventionNames
- Drug: LY2880070
- type
- EXPERIMENTAL
- label
- Part A: LY2880070 with Gemcitabine
- description
- Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
- interventionNames
- Drug: LY2880070
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Part A: LY2880070 (Metabolism Phenotype)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have an estimated life expectancy of greater than or equal to (≥)12 weeks
* Have adequate organ function
* Have received 1-4 prior systemic therapies for locally advanced or metastatic disease
* Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
* All females must have a negative serum pregnancy test result, and females of child-bearing potential must have a negative urine pregnancy test result, prior to the first study treatment
* Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit
For Part A
* Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
* For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype
For Part B
* Have advanced or metastatic colorectal cancer, triple negative breast cancer (per American Society of Clinical Oncology-College of American Pathology guidelines), epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer
* For TNBC:
* Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any beast cancer that expresses \<1% estrogen receptor (ER) and \<1% progesterone receptor (PR) and is Her2 negative
* For Colorectal (CRC):
* Must have histologically confirmed advanced or metastatic colorectal cancer
* For Ovarian Cancer:
* Must have histologically confirmed advanced or metastatic epithelial ovarian cancer
* Must be eligible to receive Gemzar (GEM) and not refractory to GEM/carboplatin
* Must have the ability to tolerate GEM
* May have received GEM as previous therapy
* For Endometrial cancer:
* Must have histologically confirmed endometrial cancer that is metastatic or locally advanced
* Must have failed at least 1 prior chemotherapy
* For STS:
* Must have histologically confirmed STS that is metastatic or locally advanced
* Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT inhibitor
* Must have failed at least 1 prior chemotherapy
* For Pancreatic Cancer:
* Must have histologically confirmed pancreatic cancer that is metastatic or locally advanced
* Must have failed at least 1 prior chemotherapy regimen
* For Part C
* Participants with high grade serous ovarian cancer (HGSOC) will be screened for specific genetic signatures
Exclusion Criteria:
* Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
* Have symptomatic central nervous system (CNS) metastasis
* Females who are pregnant or nursing
* Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
* Have a corrected QT interval (QTcB) greater than (\>) 470 milliseconds (msec) (female) or \>450 msec (male), or a history of congenital long QT syndrome
* Have had a bone marrow transplant
* Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product
* Have had radiation therapy to \>25% of bone marrow
* For Part B
* Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered curedReferences
Publications (4)
- RESULTW.H. Miller, A.F. Shields, D. Provencher, L. Gilbert, G. Shapiro, A.M. Oza, J. Spratlin, S. Lheureux, G. Bhat, S. Salvador, P. Nunes, S. Lau, I. Weiner, J. Keene, S. Zaknoen, P. Smith, J. Stille, D. Vincett, Q.S-C. Chu, 537P A phase I/II study of oral chk1 inhibitor LY2880070 in combination with low-dose gemcitabine in patients with advanced or metastatic ovarian cancer, Annals of Oncology, Volume 33, Supplement 7, 2022, Pages S793-S794, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2022.07.665. (https://www.sciencedirect.com/science/article/pii/S0923753422025169)
- RESULTDOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.
- RESULTDOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.
- DERIVEDHuffman BM, Feng H, Parmar K, Wang J, Kapner KS, Kochupurakkal B, Martignetti DB, Sadatrezaei G, Abrams TA, Biller LH, Giannakis M, Ng K, Patel AK, Perez KJ, Singh H, Rubinson DA, Schlechter BL, Andrews E, Hannigan AM, Dunwell S, Getchell Z, Raghavan S, Wolpin BM, Fortier C, D'Andrea AD, Aguirre AJ, Shapiro GI, Cleary JM. A Phase I Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-dose Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma. Clin Cancer Res. 2023 Dec 15;29(24):5047-5056. doi: 10.1158/1078-0432.CCR-23-2005. PMID 37819936