NCT04678102: CREATIVE

Chk2 Inhibitor for Recurrent EpitheliAl periToneal, fallopIan or oVarian cancEr (CREATIVE Phase IA Trial)

Status unknown Phase 1 Last updated 26 June 2023

What this trial tests

Phase 1 trial testing PHI-101 administration in Platinum-resistant Ovarian Cancer in 36 participants. Status unknown.

Timeline

17 December 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	17 December 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across South Korea

Drugs / interventions tested

• PHI-101 administration — full drug profile →

Conditions studied

• Platinum-resistant Ovarian Cancer — all drugs for Platinum-resistant Ovarian Cancer →
• Platinum-refractory Ovarian Carcinoma — all drugs for Platinum-refractory Ovarian Carcinoma →
• Platinum-Resistant Fallopian Tube Carcinoma — all drugs for Platinum-Resistant Fallopian Tube Carcinoma →
• Platinum-Resistant Primary Peritoneal Carcinoma — all drugs for Platinum-Resistant Primary Peritoneal Carcinoma →

Sponsor

Seoul National University Hospital

Who can join

19 and older, female only, with Platinum-resistant Ovarian Cancer or Platinum-refractory Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to assess the safety and tolerability of PHI-101 in patients with platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer. This study also evaluates the pharmacokinetics of PHI-101 and efficacy of PHI-101 during treating platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer.

PHI-101 is a CHK2 inhibitor that is a checkpoint kinase binding specifically to CHK2, rather than CHK1, and it inhibits the DDR system by inhibiting the ATM-CHK2 pathway, which is activated in response to DSBs. When a high-grade serous ovarian (HGSO) cancer cell line and various ovarian cancer cell lines (CAOV3, OVCAR3, SK-OV-03, and SW626) were treated with PHI-101 in a non-clinical study, the therapeutic effect of PHI-101 against ovarian cancer was demonstrated by a decrease in viability of ovarian cancer cells. In addition, a stronger growth inhibition effect was observed compared to that of treatment with olaparib or rucaparib alone, and a much stronger inhibition effect was observed when concomitantly used with paclitaxel, cisplatin, and topotecan. Based on the aforementioned results of the non-clinical studies, the potential of PHI-101 as a new treatment or concomitant cytotoxic chemotherapeutics for patients with ovarian cancer who are resistant to existing antineoplastic drugs was confirmed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug resistance in ovarian cancer: from mechanism to clinical trial.
   Wang L, Wang X, Zhu X, Zhong L, et al · · 2024 · cited 139× · PMID 38539161 · DOI 10.1186/s12943-024-01967-3
2. Leveraging the replication stress response to optimize cancer therapy.
   Cybulla E, Vindigni A. · · 2023 · cited 109× · PMID 36323800 · DOI 10.1038/s41568-022-00518-6
3. Organelle-targeted therapies: a comprehensive review on system design for enabling precision oncology.
   Yang J, Griffin A, Qiang Z, Ren J. · · 2022 · cited 103× · PMID 36402753 · DOI 10.1038/s41392-022-01243-0
4. The changing scenario of drug discovery using AI to deep learning: Recent advancement, success stories, collaborations, and challenges.
   Chakraborty C, Bhattacharya M, Lee SS, Wen ZH, et al · · 2024 · cited 25× · PMID 39257717 · DOI 10.1016/j.omtn.2024.102295
5. Kinase Inhibitors in the Treatment of Ovarian Cancer: Current State and Future Promises.
   Skorda A, Bay ML, Hautaniemi S, Lahtinen A, et al · · 2022 · cited 24× · PMID 36551745 · DOI 10.3390/cancers14246257
6. A phase IA dose-escalation study of PHI-101, a new checkpoint kinase 2 inhibitor, for platinum-resistant recurrent ovarian cancer.
   Park SJ, Chang SJ, Suh DH, Kong TW, et al · · 2022 · cited 24× · PMID 34980026 · DOI 10.1186/s12885-021-09138-z
7. The future of pharmaceuticals: Artificial intelligence in drug discovery and development.
   Fu C, Chen Q. · · 2025 · cited 18× · PMID 40893437 · DOI 10.1016/j.jpha.2025.101248
8. DNA repair and the contribution to chemotherapy resistance.
   Nesic K, Parker P, Swisher EM, Krais JJ. · · 2025 · cited 16× · PMID 40420317 · DOI 10.1186/s13073-025-01488-8