Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04335253
Other study ID # IO-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 18, 2020
Est. completion date April 7, 2022

Study information

Verified date September 2021
Source iTeos Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers.


Description:

Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 7, 2022
Est. primary completion date April 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448 2. Be more than18 years of age on day of signing informed consent. 3. Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available 4. Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated 5. Have an ECOG performance status of Grade 0 to 1. 6. Have adequate organ function. 7. Agree to use adequate contraception during the treatment if required. Exclusion Criteria: 1. Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose. 2. Has undergone major surgery within 5 weeks before initiating treatment. 3. Has received prior radiotherapy within 2 weeks of start of IP. 4. Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible. 5. Has known CNS metastases. 6. Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids. 7. Has uncontrolled or significant cardiovascular disease. 8. Has received vaccine containing live virus within 4 weeks. 9. Has known active or chronic viral hepatitis. 10. Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EOS884448
Multiple Ascending Dose

Locations

Country Name City State
Belgium GZA Ziekenhuizen campus Sint-Augustinus Antwerp
Belgium Cliniques universitaires St Luc-UCL Brussels
Belgium Institut Jules Bordet Brussels
Belgium Universitair Ziekenhuis Gent Gent

Sponsors (1)

Lead Sponsor Collaborator
iTeos Belgium SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with Adverse Events From first dose date to 90 days after the last dose (up to 48 weeks)
Primary Percentage of participants who experience a Dose Limiting Toxicity From first study treatment administration through Day 28
Primary Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors. up to 48 weeks
Secondary Mean and median Area under the curve (AUC) of EOS884448 at each dose level up to 48 weeks
Secondary Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level up to 48 weeks
Secondary Percentage of participants with Objective Response as determined by Investigator according to RECIST v1.1or per other specific response criteria according to their tumor type. From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks)
Secondary Percentage of participants with anti-drug antibodies to EOS884448 Recorded at baseline (screening), during the first 4 cycles of treatment (4 months), at end of treatment, and 30 and 90 days post last dose (approximately 48 weeks)
See also
  Status Clinical Trial Phase
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Recruiting NCT05045040 - Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03994601 - An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01393990 - A Study of LY2228820 in Participants With Advanced Cancer Phase 1
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Active, not recruiting NCT04121676 - Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03674567 - Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab Phase 1/Phase 2
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A
Completed NCT02778126 - A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer Phase 1
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT02245204 - Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers Phase 1
Terminated NCT01929941 - An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies Phase 1
Completed NCT01583777 - Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer Phase 1