A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Study sites: 19 to 20
  2. Eligibility criteria expanded, about 9 words
  3. Enrollment increased: 150 → 238 participants
    • Interventions modified
    • Trial arms changed: 2 → 10
    • Site details revised at 1 of 19 sites
  4. Enrollment target: 150 to 238 Show 6 more changesShow less
    • Interventions: NKT3964 (Drug) to Doxorubicin (Drug), NKT3964 (Drug), Paclitaxel (Drug)
    • Eligibility criteria expanded, about 281 words
    • Secondary endpoints revised (14)
    • Study description expanded, about 289 words
    • Site details revised at 2 of 19 sites
    • Study arms: 2 to 10
  5. Site details revised at 3 of 19 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Eligibility criteria shortened, about 10 words
    • Study description shortened, about 10 words
    • Site details revised at 2 of 19 sites
    v11
  2. Study sites: 14 to 19v10
  3. Study sites: 8 to 14
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints revised (14)
    • Study description shortened, about 18 words
    v9
  4. Enrollment target: 90 to 150
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: details revised at 2 of 14 entries
    • Study description expanded, about 194 words
    v8
  5. Site contacts updated at 8 of 8 sitesv7
  6. Study sites: 3 to 8v6
  7. Study sites: 1 to 3v5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2024 to Sep 19, 2024
    v4
  9. Study Identification, Study Status, Oversight, Contacts/Locationsv3
  10. Study description expanded, about 91 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NiKang Therapeutics, Inc.
2 trials monitored
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Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Ovarian Cancer
1,341 trials monitored
See 94 trials at risk
and 4 more diseases
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D). The goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.
Trial Details
NCT Number NCT06586957
Lead Sponsor NiKang Therapeutics, Inc.
Conditions
(from sponsor)		 Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Metastatic Ovarian Carcinoma +20 more
Related terms Endometrial Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Small Cell Lung Carcinoma, Stomach Neoplasms, Triple Negative Breast Neoplasms, Uterine Diseases
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov