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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY2880070 | Experimental | Multiple oral doses of LY2880070 during 21-day cycles |
|
| Part A: LY2880070 with Gemcitabine | Experimental | Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles |
|
| Part A: LY2880070 (Metabolism Phenotype) | Experimental | Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers |
|
| Part B: LY2880070 and Gemcitabine (Breast) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Part B: LY2880070 and Gemcitabine (Colorectal) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2880070 | Drug | Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose(s) | Baseline through Cycle 1 (Estimated up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dose limiting toxicities (DLTs) | Baseline through Cycle 1 (Estimated up to 21 days) | |
| Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24) | Baseline to 24-hours post dose (up to Day 20 in Cycle 1) |
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Inclusion Criteria:
For Part A
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:
For Colorectal (CRC):
For Ovarian Cancer:
For Endometrial cancer:
For STS:
For Pancreatic Cancer:
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
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| Name | Affiliation | Role |
|---|---|---|
| Email: Darcy.Vincett@ozmosisresearch.ca | Esperas Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Karmanos Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | W.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) | ||
| Result | DOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579. | ||
| Result | DOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581. | ||
| 37819936 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2025 | |
| Reset | Aug 27, 2025 | |
| Release | Oct 7, 2025 |
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| Part B:LY2880070 and Gemcitabine (Ovarian) |
| Experimental |
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Part B: LY2880070 and Gemcitabine (Endometrial) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Part B: LY2880070 and Gemcitabine (Pancreatic) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
|
| Gemcitabine | Drug | 50 to 600 milligrams per square meter of body surface area (mg/m2) |
|
|
| Peak plasma concentration (Cmax) | Baseline to 24 hours post-dose (up to Day 20 in Cycle 1) |
| Time to reach maximum plasma concentration (tmax) | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Change from baseline in white blood cell count | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Change from baseline in neutrophil count | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Change from baseline in lymphocyte count | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1) | Baseline to study completion (estimated up to 4 years) |
| Duration of objective response | Baseline to study completion (estimated up to 4 years) |
| Best response | Baseline to study completion (estimated up to 4 years) |
| Progression free survival | Baseline to study completion (estimated up to 4 years) |
| Overall survival | Baseline up to 1 year |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| University Health Network - Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0A9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| General Hospital Zadar | Zadar | 23000 | Croatia |
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Centrum Onkologii im. prof. F. Łukaszczyka | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz | Gdansk | 80-214 | Poland |
| Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o. | Krakow | 30-348 | Poland |
| Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o. | Krakow | 31-826 | Poland |
| Huffman 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. |
| Reset | Oct 21, 2025 |
| Release | Jan 16, 2026 |
| Reset | Feb 2, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2025 | Aug 27, 2025 | |||
| Oct 7, 2025 | Oct 21, 2025 | |||
| Jan 16, 2026 | Feb 2, 2026 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| D016889 | Endometrial Neoplasms |
| D012509 | Sarcoma |
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D010182 | Pancreatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D009372 | Neoplasms, Connective Tissue |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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