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Phase 1a: Dose Escalation for Metastatic Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology, San Antonio, TXMetastatic Tumor+2 MoreTACH101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialassesses the safety, effectiveness and side effects of a new oral cancer drug, TACH101, for people with advanced or metastatic solid tumors.

Eligible Conditions
  • Solid Metastatic Tumor
  • Solid Tumors
  • Advanced Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
M6223
1
Dose Escalation (Phase 1)
1
XMT-1660

Study Objectives

5 Primary · 31 Secondary · Reporting Duration: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length = 28 days)

Day 28
Phase 1b Dose Expansion: Concentration at 2 Hours Postdose (C2h) of TACH101
Phase 1b Dose Expansion: Maximum Concentration (Cmax) of TACH101
Phase 1b Dose Expansion: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101
Phase 1b Dose Expansion: Plasma Concentration of TACH101
Day 28
Phase 1 Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
Phase 1a Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
Day 201
Phase 1 Dose Escalation: Clinical Benefit Rate (CBR)
Phase 1 Dose Escalation: Duration of Response (DOR)
Phase 1 Dose Escalation: Maximum Tolerated Dose (MTD) of TACH101
Phase 1 Dose Escalation: Objective Response Rate (ORR)
Phase 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of TACH101
Phase 1a Dose Escalation: Clinical Benefit Rate (CBR)
Phase 1a Dose Escalation: Duration of Response (DOR)
Phase 1a Dose Escalation: Maximum Tolerated Dose (MTD) of TACH101
Phase 1a Dose Escalation: Objective Response Rate (ORR)
Phase 1a Dose Escalation: Recommended Phase 2 Dose (RP2D) of TACH101
Phase 1b Dose Expansion: Clinical Benefit Rate (CBR)
Phase 1b Dose Expansion: Duration of Response (DOR)
Phase 1b Dose Expansion: Objective Response Rate (ORR)
Day 28
Phase 1 Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101
Phase 1 Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101
Phase 1 Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101
Phase 1 Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101
Phase 1 Dose Escalation: Maximum Concentration (Cmax) of TACH101
Phase 1 Dose Escalation: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101
Phase 1 Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101
Phase 1a Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101
Phase 1a Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101
Phase 1a Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101
Phase 1a Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101
Phase 1a Dose Escalation: Maximum Concentration (Cmax) of TACH101
Phase 1a Dose Escalation: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101
Phase 1a Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101
Day 203
Phase 1 Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Phase 1b Dose Expansion: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Day 204
Phase 1a Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
M6223
1
Dose Escalation (Phase 1)
1
XMT-1660

Trial Design

3 Treatment Groups

Phase 1a: Dose Escalation
1 of 3
Phase 1b: Dose Expansion
1 of 3
Phase 1: Dose Escalation
1 of 3

Experimental Treatment

70 Total Participants · 3 Treatment Groups

Primary Treatment: Phase 1a: Dose Escalation · No Placebo Group · Phase 1

Phase 1a: Dose Escalation
Drug
Experimental Group · 1 Intervention: TACH101 · Intervention Types: Drug
Phase 1b: Dose Expansion
Drug
Experimental Group · 1 Intervention: TACH101 · Intervention Types: Drug
Phase 1: Dose Escalation
Drug
Experimental Group · 1 Intervention: TACH101 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 day 1 up to cycle 1 day 28 (cycle length = 28 days)

Who is running the clinical trial?

Tachyon Therapeutics, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer that has spread and is not responding to standard treatments, or there are no available treatments that can cure your cancer. Your doctor has determined that you are not suitable for other standard treatments.
You have experienced side effects from previous treatments, but they have mostly resolved or are stable and not harmful to your health. However, some ongoing side effects, such as hair loss or loss of appetite, are acceptable. If you have Grade 2 peripheral neuropathy from previous treatment with taxanes and/or platinum-based therapy, you may still be eligible to participate.
References

Frequently Asked Questions

Has the FDA granted sanction to Phase 1a: Dose Escalation?

"Our experts at Power rated the safety rating of Phase 1a: Dose Escalation as a 1 due to its status as a Phase 1 trial, indicating that there is only sparse evidence confirming efficacy and limited data backing its safety." - Anonymous Online Contributor

Unverified Answer

How many participants are included in this experiment?

"Affirmative. According to clinicaltrials.gov, this trial is in the process of selecting participants. It was posted on January 19th 2023 and most recently edited on January 25th 2023, with a need for 70 volunteers from one medical site." - Anonymous Online Contributor

Unverified Answer

Are there any open opportunities for participants to join this clinical investigation?

"Affirmative. The clinicaltrials.gov database reveals that this research is currently in need of volunteers. It was initially posted on January 19th 2023 and recently revised on the 25th of the same month. 70 individuals have to be recruited from just one trial site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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