An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Objective:

Primary Objectives:

• To assess safety and tolerability at increasing
  dose levels of IDE397 in successive cohorts of
  participants with selected advanced or
  metastatic solid tumors to estimate the
  Maximum Tolerated Dose (MTD) and/or
  Recommended Phase 2 Dose (RP2D)/schedule
  (Part 1: IDE397 Monotherapy Dose
  Escalation).
• To further assess the safety and tolerability of
  IDE397 (MTD and/or RP2D) monotherapy
  (Part 2: IDE397 Monotherapy Dose
  Expansion).
• To assess safety and tolerability at increasing
  dose levels of IDE397 in combination with
  either docetaxel, paclitaxel, gemcitabine and
  nab-paclitaxel or pemetrexed (Part 3: IDE397 Combination Therapy with docetaxel or
  paclitaxel Dose Escalation, Part 5:
  IDE397 Combination Therapy with
  Gemcitabine + nab-paclitaxel Dose Escalation,
  Part 7: IDE397 Combination Therapy with
  pemetrexed Dose Escalation).
• To further assess safety and tolerability of
  IDE397 (MTD and/or RP2D) in combination
  with either docetaxel, paclitaxel, gemcitabine
  and nab-paclitaxel or pemetrexed (Part 4:
  IDE397 Combination Therapy with docetaxel
  or paclitaxel Dose Expansion, Part 6: IDE397
  Combination Therapy with gemcitabine and
  nab-paclitaxel Dose Expansion, Part 8: IDE397
  Combination Therapy with pemetrexed Dose
  Expansion ). 
• To evaluate preliminary anti-tumor activity
  (Parts 2, 4, 6, 8).

Seconday Objectives:

• To characterize the single and multiple dose
  Pharmacokinetics (PK) of IDE397 and
  metabolite following oral administration as a
  single agent, and in combination with either
  docetaxel, paclitaxel, gemcitabine, and nabpaclitaxel or pemetrexed (all Parts).
• To evaluate drug interaction between IDE397
  and paclitaxel or docetaxel (Parts 3 and 4).
• To evaluate drug interaction between IDE397
  and nab-paclitaxel and Gemcitabine (Parts 5
  and 6).
• To evaluate drug interaction between IDE397
  and pemetrexed (Parts 7 and 8).
• To evaluate the PD effect of IDE397 as single
  agent, and in combination with either
  docetaxel, paclitaxel, gemcitabine and nabpaclitaxel, or pemetrexed (all Parts).
• To evaluate preliminary anti-tumor activity
  (Parts 1, 3, 5, 7).
• To assess efficacy of IDE397 administered as
  a single agent, and in combination with
  docetaxel, paclitaxel, gemcitabine, nabpaclitaxel and pemetrexed by Blinded Imaging
  Committee Review (BICR) (Parts 1, 2, 3, 4, 5,
  6, 7, 8).